System and method for controlling electronic communications

ABSTRACT

The approved email generation system described is capable of producing email communications using approved email templates and content that have been aligned with information regarding user access to such content. Once the approved email has been generated, the content may be verified again for accuracy and validity before being delivered to the user. When the user accesses delivered content, the approved email generation system again verifies the content and allows the user access to only the most current version of the content available. The system provides for control of the content of electronic communications to users.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. application Ser. No.14/611,012, filed on Jan. 30, 2015, which is a continuation-in-part ofU.S. application Ser. No. 14/271,134, filed on May 6, 2014, which claimspriority to U.S. Provisional Patent Application Nos. 61/820,029, filedMay 6, 2013, and 61/828,034, filed May 28, 2013, all of which are herebyincorporated by reference herein for all purposes.

TECHNICAL FIELD

The present application relates generally to systems and methods thatprovide for sending approved content to electronic communicationsrecipients, including methods and systems for building the approvedcontent and generating the approved messages for electroniccommunications such as email.

BACKGROUND

In certain fields, the ability to achieve the efficiencies associatedwith modern electronic communications such as email has been hampered bythe risks (regulatory and otherwise) of sending such electroniccommunications. An example of one field that has been so limited hasbeen the pharmaceutical sales industry, where sales reps typically arerestricted from sending email communications to prescribing doctorsbecause of the enormous risks that can flow from unapproved,uncontrolled messages. For example, a careless rep or other personnelmight send an email to a subscribing doctor suggesting off-label usesfor a drug. This could end up exposing the company employer (e.g., apharmaceutical company) to regulatory penalties or other legalliabilities.

SUMMARY

Embodiments disclosed in the present document provide amachine-implemented method for generating approved emails. The methodcomprises: establishing a controlled content repository, the controlledcontent repository being securely and controllably accessed;establishing an access protocol for the controlled content repository,whereby approved content is stored in the controlled content repositoryaccording to the access protocol and whereby the access protocolcomprises at least one set of alignment rules for determining if a firstpiece of approved content within the controlled content repository canbe made available to a first customer via an electronic message; storingthe approved content within the controlled content repository, theapproved content further being accessible according to the establishedaccess protocol; aligning the approved content within the controlledcontent repository with information from an information managementsystem; and providing an approved email generating system whichgenerates an electronic message according to the established accessprotocol for sending a piece of approved content within the controlledcontent repository to an approved customer.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the present application and itsadvantages, reference is now made to the following description taken inconjunction with the accompanying drawings, in which like referencenumbers indicate like features.

FIG. 1 illustrates an exemplary architecture for managing the buildingand sending of approved electronic communications according to someembodiments of the present invention;

FIG. 2 illustrates an example architecture for the content repository ofFIG. 1 in which content is built and organized in a controlled mannerthat facilitates efficient content generation according to someembodiments of the present invention;

FIG. 3a illustrates a screenshot showing one embodiment of the “MyAccounts” option where the user may access personalized customer mailinglists according to some embodiments of the present invention;

FIG. 3b illustrates a screenshot showing an embodiment of starting tobuild an approved email from a content page according to someembodiments of the present invention;

FIG. 4 illustrates a screenshot showing one example of the “EmailTargets” option in the mobile application (or web application) fromwhich users may select individuals from the mailing list as recipientsof an approved email according to some embodiments of the presentinvention;

FIG. 5 illustrates a screenshot of an example “Email Targets” screenwith individual email targets selected to receive an approved emailaccording to some embodiments of the present invention;

FIG. 6 illustrates a screenshot of one embodiment of an “Email Template”selection screen where the user may choose one or more customer-alignedtemplates to generate approved emails to selected customers according tosome embodiments of the present invention;

FIG. 7 illustrates a screenshot of an example approved template foremail generation with an example warning icon indicating that one ormore of the email recipients is unapproved to receive the content withinthe template or content attached to the template email according to someembodiments of the present invention;

FIG. 8 illustrates a screenshot of example pop-up screen detailing thereasons why individual customers may not be approved to receive thecontent according to some embodiments of the present invention;

FIG. 9 illustrates a screenshot of one embodiment of the signaturecapture technology available to users through the mobile application toprovide for remote opt-in for electronic communications according tosome embodiments of the present invention;

FIGS. 10a-c illustrates screenshots of an example approved emailtemplate with user-selected hyperlinks to approved content includedwithin the body according to some embodiments of the present invention;

FIGS. 10d-f illustrate screenshots of an example approved email templatewith a call to action according to some embodiments of the presentinvention;

FIGS. 11a-b illustrate screenshots of example “Preview” screens, fromwhich the user may view the approved email in the format in which it isviewable by the recipient according to some embodiments of the presentinvention;

FIG. 11c illustrates an example email confirming receipt of thecustomer's request according to some embodiments of the presentinvention;

FIG. 12 illustrates a screenshot of an example customer portal throughwhich customers may access approved content from the controlled contentrepository according to some embodiments of the present invention;

FIG. 13a-c illustrate a screenshot of one embodiment of the customerprofile information screen wherein users may have access to informationregarding approved email communication history with the customeraccording to some embodiments of the present invention;

FIG. 14 is a flowchart illustrating the providing and/or provisioning ofan approved email system according to some embodiments of the presentinvention;

FIG. 15 is a flowchart illustrating the building and sending of approvedemails according to some embodiments of the present invention;

FIGS. 16a-b illustrate a flowchart of a method for building, sending andfollowing up of an approved email with a call to action according tosome embodiments of the present invention.

FIG. 17 illustrates an example high level block diagram of a datamanagement architecture wherein the present invention may be implementedaccording to some embodiments of the present invention;

FIG. 18 illustrates an example block diagram of a computing deviceaccording to some embodiments of the present invention;

FIG. 19 illustrates an example high level block diagram of the datamanagement server according to some embodiments of the presentinvention;

FIGS. 20a-e illustrate example user interfaces for creating or editing astudy design according to some embodiments of the present invention;

FIG. 21 illustrates an example high level block diagram of a usercomputing device according to some embodiments of the present invention;

FIGS. 22a-d illustrate example user interfaces for collecting subjecttrial source data according to some embodiments of the presentinvention;

FIG. 23 illustrates an example flowchart of a method for collecting dataaccording to some embodiments of the present invention;

FIG. 24 illustrates a network system environment that includes acontrolled content repository system comprising multiple contentversions according to some embodiments of the present invention;

FIG. 25 illustrates two different electronic data capture (EDC)techniques according to some embodiments of the present invention; and

FIG. 26 illustrates a network system environment that includes acontrolled content repository system according to some embodiments ofthe present invention.

Although similar reference numbers may be used to refer to similarelements for convenience, it can be appreciated that each of the variousexample embodiments may be considered to be distinct variations.

The present embodiments will now be described hereinafter with referenceto the accompanying drawings, which form a part hereof, and whichillustrate example embodiments which may be practiced. As used in thedisclosures and the appended claims, the terms “embodiment” and “exampleembodiment” do not necessarily refer to a single embodiment, although itmay, and various example embodiments may be readily combined andinterchanged, without departing from the scope or spirit of the presentembodiments. Furthermore, the terminology as used herein is for thepurpose of describing example embodiments only, and are not intended tobe limitations. In this respect, as used herein, the term “in” mayinclude “in” and “on,” and the terms “a,” “an” and “the” may includesingular and plural references. Furthermore, as used herein, the term“by” may also mean “from,” depending on the context. Furthermore, asused herein, the term “if” may also mean “when” or “upon,” depending onthe context. Furthermore, as used herein, the words “and/or” may referto and encompass any and all possible combinations of one or more of theassociated listed items.

DETAILED DESCRIPTION

Embodiments disclosed in the present application allow for control ofemail content for communications between system users and emailrecipients (customers) by providing for a system and method forgenerating an “approved email” communication. Users may access a list ofemail templates which have been pre-generated with approved content andthen aligned with various customer attributes such as regulatorylimitations, customer preferences and demographic information in orderto ensure compliant and tailored communication between the user and thecustomer.

Such controlled email or other electronic communication generationoccurs at an interface between a repository of approved content itemsand templates along with customer relationship management (CRM)information including customer profile information and parametersincluding customer preferences and regulatory limitations or fields thatcan be used to facilitate compliance with regulatory limitations. Thesystem is capable of generating warning notices to users when contentand customer access do not align and users may choose various actions toaddress the warning notices such as excluding certain customers from thecommunication or changing email content. The customer information isfrom a customer relationship management subsystem.

In disclosed embodiments, intelligent and flexible updating of recordsmay be provided within the customer relationship management subsystem,including such approaches as communicating with third-party systems andsources in order to verify and update customer information in aneffective and timely manner, such as by using the collective informationgained by managing a cloud-based system/Software-as-a-Service (SaaS)system on behalf of multiple company customers for the disclosedembodiments.

After approved emails are constructed by the user, the content containedwithin the approved email may be once again checked for accuracy andvalidity by the system before release to the email server. When acustomer accesses content within an approved email, the customer isdirected to a customer portal through which the content is accessed. Thecustomer may be only allowed access to the most current version of theapproved content within the content repository. In this manner, thecontent received and viewable by the customer has been verified inreal-time as being compliant, approved content.

FIG. 1 is a system overview illustrating an embodiment of a controlledemail communication system 100. The presently disclosed embodimentcomprises a controlled content repository 102, a Customer RelationshipManagement (CRM) server 106, and a multichannel processing engine 108.The customer relationship management server 106 may provide access to acustomer relationship management subsystem 104, and the multichannelprocessing engine 108 may be coupled to an email server 114. In oneembodiment, the customer relationship management subsystem 104 and/orthe email server 114 may be operated by a third party. The multichannelprocessing engine 108 may be accessed by users such as company salesrepresentatives through web clients 110 or through mobile apps 112 (suchas iOS, Android, Blackberry, or Windows Mobile systems), communicatingwith the multichannel processing engine 108 through web servers 113.Although the users may be described in the present application as beingcompany sales representatives, this particular described embodiment isnot intended to limit the generality of the claims that may eventuallyissue in patents stemming from the present disclosure.

The controlled content repository 102 is designed to have a process fordeveloping approved content that is sharable across multiple users, suchas shareholders, reviewers, managers, marketing personnel, salesrepresentatives, etc. The content generated in the controlled contentrepository 102 may be accessed on a regulated basis and used to generateapproved electronic communications. This regulated basis may bedetermined, in part, by the company as a whole and additionally byinteraction with data from the customer relationship managementsubsystem 104, described in further detail below. In one embodiment,approved content, customer profile information, customer preferences,and regulatory limitations and requirements may be stored in a table inthe controlled content repository 102. In addition to storage anddevelopment of content, the controlled content repository 102 may alsostore an audit trail, tracking exact content of communications as theywere sent by the user, as well as metadata about the communications andinformation regarding the content accessed by customers.

The customer relationship management subsystem 104 contains all contactinformation that may be available to users. In addition to storage ofcontact information, the customer relationship management subsystem 104may also be capable of storing configurations regarding specificpreferences, regulatory limitations and requirements, and other fieldsthat will facilitate the generation of appropriate approved electroniccommunications, in general or on a by-recipient basis. These preferencesand/or requirements include both the preferences of the user (e.g.,maintaining account lists) as well as the preferences of the enterprise(e.g., employers of the users), discussed in further detail below. Insome examples, the approved content and email templates may bepre-processed and stored in the controlled content repository 102 andprovided to the multichannel processing engine 108 during the processfor generating an approved email. In other examples, the customerrelationship management subsystem 104 may have a content managementsubsystem and may provide the approved content and the templates.

In this embodiment, the customer relationship management subsystem 104is capable of communication with multiple sources through the customerrelationship management server 106 or through other channels to maintaina current and accurate collection of information regarding customeraccounts. The interface with the multiple sources can be, for example,through an Applications Programming Interface or API, as the APIinterface will allow compatibility with a flexible array of third-partyprovider servers. The information being updated may include, but is notlimited to, licensing information, area of practice, and location of thevarious customer contacts. In this manner, the customer relationshipmanagement subsystem 104 pulls the approved version of what representsan account or physician, which then pulls from multiple networks toensure that the information regarding an account is up-to-date. Thecustomer relationship management subsystem 104 may also be used todetermine the type of domain an email communication is deliveredthrough. A customer in Spain may receive an email from “CompanyX.es,”whereas a customer in Germany would receive the same email from“CompanyX.ge.” This may allow for additional branding options for thecompany controlling and sending the electronic communications.

With further reference to the customer relationship management subsystem104, this system may be a cloud-based customer database that provides acentral access to store and distribute consistent data across customercompanies as well as their possible third-party partners and agenciesthat are used to keep this data updated. This system can providestandard data formats and provide an easy and automated way forcustomers to have access to coordinated and frequently updated CRM dataand to use that coordinated data for sending approved electroniccommunications in accordance with the system described herein.

In an embodiment, the multichannel processing engine 108 is responsiblefor combining the customer account information from the customerrelationship management subsystem 104 with content available from thecontrolled content repository 102. Within the customer relationshipmanagement subsystem 104, customer accounts may be assigned a set ofalignment rules which determine specific pieces of content that areavailable for use from the controlled content repository 102. Themultichannel processing engine 108 may apply these rules and supply theuser with a list of approved email templates and pieces of content thatmay then be used to construct an approved email communication. Approvedemail generation occurs within the multichannel processing engine 108according to executable code computer instructions stored in executablecode storage 120.

The executable code comprises computer readable instructions stored onthe computer readable medium (the code storage medium 120). Theexecutable code storage 120 is in communication with the variouscomputing machines in the system 100 such as the customer relationshipmanagement server 106 and the multichannel processing engine 108. Thesame or another executable code storage 120 may be accessed by thepreviously described components of the controlled content repository 102for providing separate computer readable code for operating upon byprocessing machines in that system. In all cases, the code is programmedto perform the functions that are described in the present embodimentsand/or additional functions according to system design needs.

Communication between the multichannel processing engine 108 and thecustomer relationship management subsystem 104 may occur via thecustomer relationship management server 106, which acts as an interfacebetween the two. The customer relationship management server 106 may actsolely as an entry and exit point for the customer relationshipmanagement subsystem 104. The user may access the multichannelprocessing engine 108 through either a Web Client 110 or through themobile apps 112 (such as iOS, Android, Blackberry, or Windows Mobilesystems).

FIG. 2 provides a description of the controlled content repository 102with additional specific applications and interfaces connected thereto.In an embodiment, this controlled content repository 102 is acloud-based or distributed network based system for consolidating anenterprise's data, oftentimes integrating multiple content repositoriesin an enterprise into a single system having coordinated control,measuring, and auditing of data creation, access and distribution.

In an embodiment of the controlled content repository 102 for the lifesciences industry, as illustrated in the figure, this repository 102 caninclude specific data collections for the following areas and/orbusiness process-specific front-end applications 204:

The Research & Development (R&D) front end application 208 provides foran aggregation of materials in support of research and initial trialsubmissions through building organized and controlled contentrepositories within the controlled content repository 102. Elements thatcan be stored, organized, and managed through this front end includesubmission bills of materials, Drug Information Association (DIA)reference models support, and submission-ready renderings. This frontend 208 is designed to provide an interface to the controlled contentrepository 102 whereby researchers, contract research organizations(CROs), and other collaboration partners can access and/or distributecontent through a single controlled document system.

The trials front-end application 210 provides for faster and moreorganized access to trial documents and reports, while supportingseamless collaboration between sponsors, CROs, sites, investigators andother trial participants. Specific features both ease study and siteadministration as well as support the DIA trial master file (TMF)reference model. Having this front-end application providing access tothe controlled content repository 102 further provides for efficientpassing off of controlled content repository content between this phaseand other phases of the life sciences development process.

The manufacturing and quality application 212 enables the creation,review, approval and distribution of controlled documents across theorganization and with external partners in the context of materialscontrol and other manufacturing elements. The application 212 providesfunctionality in support of the manufacturing process includingwatermarking, controlled print, signature manifestation and “Read andUnderstood” signature capabilities. The documents and metadataassociated with this process is managed and stored in the controlledcontent repository 102 whereby it can be assured that the relateddocuments are not distributed in contravention of law and companypolicy.

The communications application 214 (e.g., a medical communicationsapplication) provides for communications with facilities (e.g., datageneration or processing facilities, medical facilities, etc.),including call center access, integration, and interface functionality.Particular access control features and metadata associated with thisapplication 214 include expiration and periodic review elements,multi-channel support, global documents and automatic response packagegeneration through the controlled content repository 102.

The marketing and sales application 216 application provides anend-to-end solution for the development, approval, distribution,expiration and withdrawal of promotional materials. Specific featuresinclude support for global pieces, approved Form FDA 2253 (or similarinternational forms) form generation, online document, and videoannotation, and a built-in digital asset library (DAL). Again, thecommunications may be through the controlled content repository 102.

In disclosed embodiments, there are provided a number of back-end systemapplications 220 that provide for the management of the data, forms, andother communications in the controlled content repository. For example,the back-end systems applications 220 may include a regulatorycompliance engine 222 to facilitate regulatory compliance, includingaudit trail systems, electronic signatures systems, and systemtraceability to comply with government regulations, such as 21 CFR Part11, Annex 11 and GxP-related requirements. The regulatory complianceengine 222 may include processors for developing metadata surroundingdocument and project folder accesses so from a regulatory compliancestandpoint it can be assured that only allowed accesses have beenpermitted. The regulatory compliance engine 222 may further includeprevalidation functionality to build controlled content in support ofinstallation qualification (IQ) and/or operational qualification (OQ),resulting in significant savings to customers for their systemvalidation costs.

In further disclosed embodiments, the back-end systems 220 may contain areporting engine 224 that reports on documents, their properties and thecomplete audit trail of changes. These simple-to-navigate reports showend users and management how content moves through its life cycle overtime, enabling the ability to track ‘plan versus actual’ and identifyprocess bottlenecks. The reporting engine may include processors fordeveloping and reporting life cycle and document management reportingbased on stored project data and access metadata relative to documents,forms and other communications stored in the controlled contentrepository 102.

In further disclosed embodiments, the back-end systems 220 can includean administrative portal 226 whereby administrators can controldocuments, properties, users, security, workflow and reporting with asimple, point-and-click web interface. Customers also have the abilityto quickly change and extend the applications or create brand newapplications, including without writing additional software code.

In further disclosed embodiments, the back-end systems 220 may include asearch engine 228 whereby the controlled content repository 102 candeliver simple, relevant and secure searching.

In providing this holistic combination of front-end applications 204 andback-end system applications 220, the various applications can furtherbe coordinated and communicated with by the service gateway 230, whichin turn can provide for communications with various web servers and/orweb services APIs 113. Such web servers and/or web services APIs 113 caninclude access to the content and metadata layers of some or all of thevarious applications 204 and systems 220, enabling seamless integrationamong complementary systems.

In the context of the described embodiments, the particular features andcapabilities integrate with the other elements of the controlled emailcommunication system 100 such that particular features are usable withinthe various user screens. For example, and without limitation to anyother possible combination of features, in the below-describeddescription of generating an approved electronic communication, theabove-described search portal can be used to search for approvedattachments (i.e. content) within the controlled content repository 102which may be then attached to one of the template emails being preparedfor sending to a customer. And the synergy of combining these particularsystems is that the generation of the controlled content can be done ina controlled fashion such that the approved content can be sent tocustomers with greater confidence in the integrity of the data beingsent.

FIG. 3a illustrates an embodiment screenshot 302 of a “My Accounts”interface in a web-based or mobile interface within a web-based system110 or mobile system 112 (see FIG. 1). From this screen 302, a user mayselect an individual account from a list of existing physician or otherclinical accounts within the customer relationship management subsystem104. By selecting a specific individual account from the “My Accounts”screen 302, the user can be taken to a screen containing current contactinformation for the selected account as stored in the customerrelationship management subsystem 104. From this screen, users may beginconstructing an approved email to the individual customers by selectinga “Compose Email” link on the screen. In this embodiment, there areadditional options within the web-based or mobile application 110, 112for sending an individual customer an approved email. From the “MyAccounts” screen 302 shown in FIG. 3a , the user may also click on ormouse over the “Action” sheet shown in this embodiment to the right ofthe contact name to get a pop-up window and select a “Send Email” link310 in the pop-up window. The user may click on a link 305 to updateinformation of the accounts.

A user may also begin constructing an email from a content page, e.g.,when the user is viewing a document or a video on his screen. FIG. 3billustrates an embodiment screenshot 352 of a “Call Report” interface ina web-based or mobile interface within a web-based system 110 or mobilesystem 112 (see FIG. 1). While viewing a Call Report 360 on screen 352,a user may decide to send content related to some topics in the CallReport. The user may click on or mouse over the “Action” sheet next tothe “Sign” link shown in this embodiment to get a pop-up window and thenselect a “Send Email” link 355 in the pop-up window. After that, thescreenshot 302 may be displayed for the user to build an approved email.Because the described system including the controlled content repository102 provides for a coherent and controlled access to the approvedcontent for email communications, it can be made quite flexible as toproviding consistently formatted and approved content from variousapplications and/or specific screenshots within applications.

Referring now to FIG. 4, by selecting the “Account Lists” 320 on theleft hand side of the screen in FIG. 3a , users may access personally orinstitutionally pre-constructed lists 410 of individual customers asconfigured in the customer relationship management subsystem 104. Fromthis screen 402, the user may also select a number of individualcustomer accounts 420 with whom they wish to communicate. Once desiredcustomers have been selected from the list, which could include theselecting of all customers in the list, the user may begin building anapproved email to the selected customers through the web-based or mobileclient application 110, 112. The email may be constructed within themultichannel processing engine 108 from the accessible content providedby the controlled content repository 102 which has been aligned with thecustomer information provided by the customer relationship managementsubsystem 104.

FIG. 5 illustrates an exemplary screenshot 502 in which the user beginsconstructing the approved email by selecting an “Email Targets” link505. The link icon may also contain the number of selected customers inparentheses. In this embodiment, the “Send Email” links 510 appear afterthe customer selection of the “Email Targets” link 505.

Shown in FIG. 6, by selecting the “Send Email” link, the user may accessthe “Email Generation Wizard.” From this screen 602, a user may accesspre-approved, controlled email templates 604 that are available andapproved for the specific group of customers selected. From thisapproved list, the user may select multiple templates. After desiredtemplates are selected, individual tabs appear at the top of the screenand within each tab is a separate approved email which may be sent tothe selected customers.

The user may access an individual template, as shown in the screenshot702 of FIG. 7, by selecting the appropriate tab 710. The template mayalso display a warning icon 720, shown in the top left of FIG. 7, whichindicates that one or more of the selected individuals may be restrictedfrom receiving the chosen template with its current content. Thiswarning is generated from information contained within the customerrelationship management subsystem 104. The user may select this icon720, which generates a pop-up window 802 containing specific warninginformation for all potential recipients who may be currently restrictedfrom receiving the content, shown in FIG. 8. Recipients may be removedfrom the email list on this screen by selecting the appropriate icon.

Warnings generated on the pop-up screen 802 illustrated in FIG. 8 mayappear for reasons that include, but are not limited to, regulatorylimitations, customer preferences, demographic information, a customer“opt-out” option where the customer has requested to not have thecontent delivered; the absence of a customer “opt-in” option where thecustomer may not receive the communication without prior approval; orthat the most current information contained within the customer accountprofile no longer allows access to the current content delivered by thecontrolled content repository 102. Information regarding regulatorylimitations, customer preferences, demographic information, the “opt-in”or “opt-out” status of individual customer accounts is stored within thecustomer relationship management subsystem 104.

In an embodiment, as shown in FIG. 9, the user may access an “opt-in”request 902 from the recipient of the email through the web-based ormobile client applications 110, 112. In this embodiment, the user mayhave access to signature capture technology, which allows for instant,remote customer approval along with the appropriate signature 905.

Once all warnings are cleared, or all restricted recipients are removedfrom the list, the user may once again have access to the approved emailtemplate 1002 as illustrated in FIG. 10a . Email templates may be either“branded” with imagery 1003 or may be presented in a plain, text-onlyformat, selectable by the user. As illustrated in FIG. 10a , the usermay have the ability to personalize the email content by free-texting inthe text box 1004 supplied within the template. This customizable textbox 1004 may also be regulated to ensure compliance by limiting thenumber of characters that may be typed in the box and by constructing“libraries” of restricted words for each customer that may not be usedin the box. The information used to regulate the text box may beaccessed from the customer relationship management subsystem 104, andconfiguration of these regulatory parameters may be designated by boththe company, by the specific customer, and/or by specific regulation.Within the approved template, the user may choose from approved contentto be included in the body of the email.

The user may select the “Select Documents to Share” icon 1010 within thetemplate, which generates a pop-up screen 1020 (see FIG. 10b )containing a list of approved content from within the controlled contentrepository 102 that has been aligned with the customer informationretrieved from the customer relationship management subsystem 104. Fromthe pop-up screen 1020, the user may select multiple content items to beincluded within the body in the form of one hyperlink per selectedcontent item. As the content items are selected, they are added to thebody of the email as individual tiles 1030 as illustrated in the centerof FIG. 10b . The list of content items may be rearranged by the user bydragging the tiles into the desired order. The user may preview theapproved email on the web-based or mobile applications 110, 112 as itwill be received by the customer by selecting the “magnifying glass”icon 1040 located within the template screen. The user may then returnto the edit function by selecting an “editing” icon or clicking outsidethe document selection pop-up screen 1020.

From this continued editing screen 1050 of FIG. 10c , the user may alsoselect a customized valediction from a drop-down menu located within thetemplate 1050. The overall approved content authoring system describedherein includes selection capabilities that are highly flexible, highlyconfigurable, and may be applicable to any place within the approvedemail template. The user may then send the email to selected recipientsusing the “Send” icon 1060 illustrated in FIG. 10 c.

FIGS. 10d-f illustrate screenshots of another example approved emailtemplate. The user may select a “Select Call to Action Items” icon 1071within the template in FIG. 10d , which generates a pop-up screen 1072(see FIG. 10e ) containing a list of call to action items that have beenaligned with the customer information retrieved from the customerrelationship management subsystem 104. The call to action items mayinclude Request Visit 1073, Request Sample 1074, and Request Invitation1075. From the pop-up screen 1072, the user may select one or more callto action items to be included within the body of the email to be sent.As the call to action items are selected, each of them may be added tothe body of the email as an individual clickable area, e.g., a hyperlinkor a button 1076 as illustrated in FIG. 10f . The email may havemultiple call to action items and they may be rearranged by the user bydragging the tiles into the desired order.

In one implementation, instead of providing the pop-up screen 1072 andthe list of call to action items shown in FIG. 10e , the multichannelprocessing engine 108 may determine, with the customer informationretrieved from the customer relationship management subsystem 104, thebest call to action item to be included in the email. For example, ifthe customer requested a visit before, the best call to action item tobe included may be “Request Sample”. The preconfigured call to actionitem may then be included in the template.

The communications between the mobile applications 112 or the webclients 110 and the multichannel processing engine 108 may use anycommunication protocols between a web client and its server, e.g.,HttpPost.

In one embodiment, the content contained within the generated email maybe once again checked for accuracy and validity by the system justbefore releasing. Once the approved email is generated in themultichannel processing engine 108 and the user selects the “Send” icon,the communication is then sent to the controlled content repository 102for final verification of the accuracy and validity of the selectedcontent. The controlled content repository 102 may also store audittrail data 150 which documents and retains information that may include,but is not limited to, recipient information, time stamp data, and themost current version number of any content included within the approvedemail. The communication is then sent back to the multichannelprocessing engine 108, where it may be routed through an email server114 and then delivered to the customer's preferred inbox. Themultichannel processing engine 108 may send only enough information tothe email server 114 for the email server 114 to create an email, andthe email server 114 may create the actual email to be sent to thecustomer. The email server 114 may collect and distribute the outboundemail content, but it may also collect interaction information from thecustomer regarding clicks, views, and other statistics regardingcustomer usage. As shown in FIG. 1, this information may then be postedback to the multichannel processing engine 108 as CRM updates 111 andsent through the customer relationship management server 106 to bedeposited in the customer relationship management subsystem 104 asinformation contained within the customer account profile. The emailsent may also be stored in the customer relationship managementsubsystem 104.

As shown in the approved email preview screen 1102 illustrated in FIG.11a , when an approved email is opened by the customer, the customer mayhave immediate access to communications as they appeared in the“preview” screens or thumbnails available to the user through theweb-based or mobile applications 112. This communication 1102 includesthe readable text and a tiled list of approved content hyperlinks, shownin the figure. The recipient may choose to view the content by selectingthe appropriate content icon. In an embodiment of the system, therecipient may select the “view pdf” hyperlink 1110 within the email,which will redirect the recipient to the customer portal screen 1202,shown in FIG. 12. Each recipient has the ability to custom-configure thespecific URL to be loaded as the “landing page” for clicks from theapproved emails.

This arrangement allows for the direction of customers to specificportals. Within the portal 1202, the recipient may view the full text ofthe content that was included as a tile within the body of the originalapproved email. The content is accessed directly from the controlledcontent repository 102 to ensure that the most up-to-date information isdisplayed when the customer accesses the selected content. If thecontent has been updated to a newer version since the user constructedthe approved email, then the hyperlink included in the approved emailwill automatically connect the customer to the most up-to-date versionof the selected content. Information regarding the content versionviewed by the customer may be stored with other pertinent informationabout the customer experience in the audit trail within the controlledcontent repository 102. In one embodiment, the controlled contentrepository 102 may create a token for the approved content to be sentwith the approved email. The token may have information about whichpiece of content to show to the customer, and direct the customer to theright content. In one embodiment, even when the content is updated afterthe email is sent, the token may direct the customer to the latestversion of the content.

The communication 1102 may also include one or more call to action items1140 as illustrated in FIG. 11b . If the user clicks on the clickablearea for a call to action item, he/she may receive an email 1150confirming receipt of the request, as shown in FIG. 11 c.

Illustrated in FIG. 13a-b is an embodiment of the system that allows theuser access to information regarding specific communications. Thisinformation is stored in the customer relationship management subsystem104 along with customer account information. The user may access thisinformation through either mobile apps 112 or through web clients 110.The information available may include, but is not limited to, the numberof times the approved email communication has been opened by thecustomer, the number of clicks executed, type of device used to accessthe communication, platform used when accessing the content, andlocation when the communication was viewed.

FIG. 14 is a flowchart illustrating the building and/or provisioning ofexemplary elements of an approved email system in accordance with theembodiments disclosed in the present application. The method starts andblock 1400, after which the system builders and/or administratorsestablish a controlled content repository 102 at block 1402. Asdescribed herein, the controlled content repository is designed to besecurely and controllably accessed such that only authorized users canbuild the controlled content therein. To ensure the integrity andsecurity of the controlled content repository 102, an access protocol isestablished at block 1402. The access protocol may be defined bycomputer instructions stored in the computer readable memory orexecutable code storage 120. By the computer instructions storedtherein, the multichannel processing engine 108 is thereby able tocontrol access to the controlled content repository 108 in accordancewith the principles described in the present application.

At block 1406, one or more users establish approved content to be storedin the controlled content repository 102 under the control of the accessprotocol established at block 1402 (or as that protocol is later changedor updated). At block 1408, a system designer or other admin establishesor updates email templates that approved content senders can pick andchoose from in building approved email content messages. At block 1410,a customer relationship management (CRM) system is accessed such thatthe approved emails can be addressed to customer contacts of theenterprise or salesperson for the enterprise who is engaging in themarketing, manufacturing, clinical trials, or other activity describedherein. At block 1412, the actual email generation system is providedthat interfaces with the approved content, the access protocol, theemail templates, and/or the customer relationship management system.This email generation system, or more specifically the multichannelprocessing engine 108, is accessed by senders of approved email contentas described in the present application.

It should be appreciated that as previously discussed, the customerrelationship management system 104/106 may be further operable tocommunicate with multiple sources of information to build a current andaccurate collection of information regarding customer accounts. Itshould also be appreciated that to facilitate such communications, atleast one of the multiple sources of information that might communicatewith the custom relationship management system 104/106 may communicatewith external servers that belong to one or more third-party partners oragencies through an Application Programming Interface (“API”) wherebythe customer relationship management system can flexibly receive dataupdates from the one or more third-party partners or agencies. Theaccess protocol that is established may also include a set of alignmentrules that determine specific pieces of approved content that areavailable to the selected customers from the controlled contentrepository.

While FIG. 14 is described in basic terms regarding its generaloperation as a controlled content access system, it should beappreciated that such a system is described herein with multiplespecific implementations. Such specific implementations can befacilitated through front-end applications in the context of supportingresearch, development, and initial trial submissions as previouslydescribed. Other front-end applications as previously described includemanage access and/or distribution of trial documents and reports insupport of ongoing trials, materials control and/or manufacturingprocess controls, communications with facilities in support of facilityoperations, and the development and distribution of promotionalmaterials as related to regulatory restricted products such asprescription drugs.

To facilitate the compliance with government regulation, a regulatorycompliance engine can be provided to review content and the accessprotocols and to ensure that only approved content authored by properlyauthorized individuals and according to required controls can bedistributed to permitted possible customers or other content recipientsin accordance with government regulations.

Next with regard to FIG. 15, a method for generation of approved emailcontent is described. In particular, FIG. 15 shows at block 1500 thestart of the process, after which at block 1502 an email author orprospective sender can choose a template from a set of customizabletemplates. In this way the email authors or prospective senders do nothave to recreate content every time an email campaign is beginning. Atblock 1504, the user selects the desired content from the approvedcontent repository 102, and the user at block 1506 selects the desiredrecipients or customers from the CRM database 104.

Still referring to FIG. 15, the system, or more specifically themultichannel processing engine 108 confirms that the approved contentand form of email may permissibly be sent by the prospective emailsender to the customers or other selected recipients at 1508 based onfactors including but not limited to regulatory limitations, customerpreferences, demographic information, or the “opt-in” or “opt-out”status of individual customer accounts. Once that has been confirmed inaccordance with the access protocol, the multichannel processing engine108 can begin building and sending the emails in accordance with theuser's selections or as modified in accordance with the access protocol,regulator engine, and or other system controls, at 1510. The contentcontained within the approved email may be checked for accuracy andvalidity by the system before release to the email server 114. If theemail is created when the user is offline, the content contained in theapproved emails may be checked again after the user is back online,before they are sent to the email server.

FIGS. 16a-b illustrate a flowchart of a method for building, sending andfollowing up of an approved email with a call to action. The process maystart at 1600, after which at block 1602 a set of customizable templatesmay be displayed for an email author or prospective sender to choosefrom. A chosen template may have a “Select Call to Action Items” button1071, as shown in FIG. 10 d.

If the user clicks on or mouses over the “Select Call to Action Items”button 1071 at 1604, a pull-down menu or pop-up window 1072 may bedisplayed at 1606, as shown in FIG. 10 e.

At block 1608, the user may select one or more desired call to actionitems. At 1610, the user may select the desired content from theapproved content repository 102. At 1612, the user may select thedesired recipients or customers from the CRM database 104.

In response, the system, or more specifically the multichannelprocessing engine 108 may confirm that the approved content, the call toaction items and the form of email may permissibly be sent by theprospective email sender to the customers or other selected recipientsat 1614 based on factors including but not limited to regulatorylimitations, customer preferences, demographic information, or the“opt-in” or “opt-out” status of individual customer accounts. Once thathas been confirmed in accordance with the access protocol, themultichannel processing engine 108 can begin building and sending theemails in accordance with the user's selections or as modified inaccordance with the access protocol, regulator engine, and or othersystem controls, at 1616. The content contained within the approvedemail may be checked for accuracy and validity by the system beforerelease to the email server 114. If the email is created when the useris offline, the content contained in the approved emails may be checkedagain after the user is back online, before they are sent to the emailserver.

The multichannel processing engine 108 may further check the data in theCRM subsystem 104 to find out if the approved content and/or the call toaction items have been sent to the recipient, and if yes, how manytimes. In one embodiment, the times that the approved content or thecall to action items have been sent may be displayed in a pop-up window,so that the user may determine if the approved content should be sent tothe recipient again.

The email is then sent to the recipient, and the recipient's accountinformation in the CRM subsystem 104 may be updated at 1617 to indicatethat the email, including the call to action, is sent.

At 1618, it may be determined if the recipient clicks on the clickablearea in the email for the call to action, e.g., Request Invitation. Ifyes, at 1620, the recipient's account information in the CRM subsystem104 may be updated to indicate that the recipient has responded to thecall to action and has requested invitation. At 1622, the multichannelprocessing engine 108 may build and send the email to acknowledgereceipt of the request, as shown in FIG. 13c , and the recipient'saccount information in the CRM subsystem 104 may be updated accordingly.

The invitation may be sent to the recipient at 1624 and the recipient'saccount information in the CRM subsystem 104 may be updated to includethe sending of the invitation. In one embodiment, the invitation is sentvia a second approve email with the multichannel processing engine 108.

The recipient's account information in the CRM subsystem 104 maycontinue to be updated with follow up activities at 1626, e.g., if therecipient has accepted the invitation, if samples have been sent, and/orif the recipient is visited by the user. Accordingly, the sender mayavoid unnecessarily duplicating the efforts.

The process may end at 1630.

The flowcharts do not mean to limit the sequence of the steps. In oneexample, the controlled content repository 102 may determine in advance,before a template is chosen at 1502, if a piece of content can be sentto a customer and store the result. The result may be stored as a partof metadata for the content in the controlled content repository 102.During the generation of the approved email, the multichannel processingengine may check information in the controlled content repository 102,instead of the customer relationship management subsystem 104, to decideif a piece of content can be sent to a customer.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. Thus, the breadth and scope of a preferred embodiment shouldnot be limited by any of the above described exemplary embodiments, butshould be defined only in accordance with the claims and theirequivalents for any patent that issues claiming priority from thepresent provisional patent application.

For example, although the embodiments are described with a customerrelationship management subsystem 104, the customer information andcontent may be from other types of information management systems, e.g.,a Closed Loop Marketing (CLM) system. In addition, the multichannelprocessing engine 108 is shown to communicate with only one customerrelationship management subsystem 104 in the drawings, but it maycommunicate with more customer relationship management subsystems. Forexample, as referred to herein, a machine or engine may be a virtualmachine, computer, node, instance, host, or machine in a networkedcomputing environment. Also as referred to herein, a networked computingenvironment is a collection of machines connected by communicationchannels that facilitate communications between machines and allow formachines to share resources. Network may also refer to a communicationmedium between processes on the same machine. Also as referred toherein, a server is a machine deployed to execute a program operating asa socket listener and may include software instances.

In all descriptions of “servers” or other computing devices herein,whether or not the illustrations of those servers or other computingdevices similarly show a server-like illustration in the figures, itshould be understood that any such described servers or computingdevices will similarly perform their described functions in accordancewith computer-readable instructions stored on a computer-readable mediathat are connected thereto.

Resources may encompass any types of resources for running instancesincluding hardware (such as servers, clients, mainframe computers,networks, network storage, data sources, memory, central processing unittime, scientific instruments, and other computing devices), as well assoftware, software licenses, available network services, and othernon-hardware resources, or a combination thereof.

A networked computing environment may include, but is not limited to,computing grid systems, distributed computing environments, cloudcomputing environment, etc. Such networked computing environmentsinclude hardware and software infrastructures configured to form avirtual organization comprised of multiple resources which may be ingeographically disperse locations.

The approved content may be in any format, e.g., text, audio, video,picture, multimedia, or PDF.

FIG. 17 illustrates an example high level block diagram of a datamanagement architecture 1700 wherein the present invention may beimplemented. As shown, the architecture 1700 may include a datamanagement system 1710, and a plurality of user computing devices 1720a, 1720 b, . . . 1720 n, coupled to each other via a network 1750. Thedata management system 1710 may include a data storage system 1711 and adata management server 1712. The data storage system 1711 may have twoor more repositories, e.g., 1711 a, 1711 b, 1711 c, . . . and 1711 n.The network 1750 may include one or more types of communicationnetworks, e.g., a local area network (“LAN”), a wide area network(“WAN”), an intra-network, an inter-network (e.g., the Internet), atelecommunication network, and peer-to-peer networks (e.g., ad hocpeer-to-peer networks), which may be wired or wireless.

The user computing devices 1720 a-1720 n may be any machine or systemthat is used by a user to access the data management system 1710 via thenetwork 1750, and may be any commercially available computing devicesincluding laptop computers, desktop computers, mobile phones, smartphones, tablet computers, netbooks, and personal digital assistants(PDAs). A client application 121 may run from a user computing device,e.g., 1720 a, and access data in the data management system 1710 via thenetwork 1750.

The data storage system 1711 may store data that client applications(e.g., 121) in user computing devices 1720 a-1720 n may access and maybe any commercially available storage devices. Each content repository(e.g., 1711 a, 1711 b or 1711 n) may store a specific category of data,and allow users to interact with its data in a specific businesscontext. It should be appreciated that content repositories may beseparate logic sections in a same storage device.

The data management server 1712 is typically a remote computer systemaccessible over a remote or local network, such as the network 1750. Thedata management server 1712 may store a data management controller 1712a and a data collection controller 1712 b for controlling management andcollection of the data, including the method to be discussed with FIG.23. The data management server 1712 could be any commercially availablecomputing devices. Although only one server is shown, it should beappreciated and the data management system 1710 may have a plurality ofservers and the controllers 1712 a and 1712 b may be in separateservers. A client application (e.g., 121) process may be active on oneor more user computing devices 1720 a-1720 n. The corresponding serverprocess (e.g., 1712 a and 1712 b) may be active on the data managementserver 1712. The client application process and the corresponding serverprocess may communicate with each other over the network 1750, thusproviding distributed functionality and allowing multiple clientapplications to take advantage of the information-gathering capabilitiesof the data management system 1710.

In one implementation, the architecture 1700 may be used for collectingand managing data, e.g., trial data. In some embodiments, a trial asdescribed in this disclosure may refer to a clinical trial. A firstrepository (e.g., 1711 a) may be used by a first sponsor (e.g., apharmaceutical company) to store a first study design received from afirst user computing device (e.g., 1720 a). The first study design maydefine the infrastructure and lifecycle of the study, and may compriserules (e.g., for queries, derived values, notifications and displayingevents, forms and items), a casebook (i.e., a doctor's binder), eventgroups, events (e.g., subject visits), forms which comprise segregatesections and fields, item groups and items. In one example, a studydesign may define a particular study, i.e., each subject may have tenvisits, and each visit may have three forms. There may be a workflowassociated with each visit, e.g., what needs to be done at each visit.In some embodiments, a subject may comprise or refer to one or morepatients.

In one implementation, the first study design may be stored asdefinition objects in the first repository 1711 a, specifying what isrequired to happen on each site during the study. The first repository1711 a may also store electronic records of the first study. In oneimplementation, the electronic records may be EDC data. Trial sourcedata (e.g., associated with a subject) may be captured at the usercomputing devices, and the aggregated and obfuscated data may be storedas EDC data in the first repository 1711 a. The data management system1710 may have an interface for receiving EDC data collected in trialsand a reporting tool for analysis of the EDC data.

The second repository 1711 b may be used by a first site (e.g., ahospital) of the first study to store trial source data from a seconduser computing device (e.g., 1720 b), and a third repository (e.g., 1711c) may be used by a second site of the first study to store trial sourcedata from a third user computing device (e.g., 1720 c). The trial sourcedata (e.g., three blood pressure values of a subject taken during onevisit) in the second repository 1711 b may be converted to EDC data(e.g., the average of the three blood pressure values) automatically,and then stored in the first repository 1711 a as EDC data. Similarly,the trial source data in the third repository 1711 c may be converted toEDC data automatically, and then stored in the first repository 1711 aas EDC data. In one implementation, the trial source data may beconverted to the EDC data at the client application 121, and the EDCdata is transmitted to the data management server 1712. In oneimplementation, the trial source data may be transmitted to therepository 1711 b or 1711 c via the data management server 1712, andconverted to the EDC data at the data management server 1712. The EDCdata is then stored in the repository 1711 a. Data in the secondrepository 1711 b and the third repository 1711 c may be synchronizedwith that in the first repository 1711 a regularly or from time to timewhen new data entries are received from user computing devices. Thefirst study design may be transmitted to the second repository 1711 band the third repository 1711 c. The second repository and the thirdrepository may be synchronized with the first repository for updates tothe first study design.

In one implementation, the data management system 1710 may be amulti-tenant system where various elements of hardware and software maybe shared by one or more customers. For instance, a server maysimultaneously process requests from a plurality of customers (e.g.,sponsors, sites, etc.), and the data storage system 1711 may storecontent for a plurality of customers (e.g., sponsors, sites, etc.). In amulti-tenant system, a user is typically associated with a particularcustomer. In one example, a user could be an employee of one of a numberof pharmaceutical companies or trial sites which are tenants, orcustomers, of the data management system 1710.

In one embodiment, the data management system 1710 may run on a cloudcomputing platform. Users can access content on the cloud independentlyby using a virtual machine image, or purchasing access to a servicemaintained by a cloud database provider.

In one embodiment, the data management system 1710 may be provided asSoftware as a Service (“SaaS”) to allow users to access the datamanagement system 1710 with a thin client.

FIG. 18 illustrates an example block diagram of a computing device 200which can be used as the user computing devices 1720 a-1720 n, and thedata management server 1712 in FIG. 17. The computing device 200 is onlyone example of a suitable computing environment and is not intended tosuggest any limitation as to scope of use or functionality. Thecomputing device 200 may include a processing unit 201, a system memory202, an input device 203, an output device 1804, a network interface 205and a system bus 206 that couples these components to each other.

The processing unit 201 may be configured to execute computerinstructions that are stored in a computer-readable medium, for example,the system memory 202. The processing unit 201 may be a centralprocessing unit (CPU).

The system memory 202 typically includes a variety of computer readablemedia which may be any available media accessible by the processing unit201. For instance, the system memory 202 may include computer storagemedia in the form of volatile and/or nonvolatile memory such as readonly memory (ROM) and/or random access memory (RAM). By way of example,but not limitation, the system memory 202 may store instructions anddata, e.g., an operating system, program modules, various applicationprograms, and program data.

A user can enter commands and information to the computing device 200through the input device 203. The input device 203 may be, e.g., akeyboard, a touchscreen input device, a touch pad, a mouse, amicrophone, and/or a pen.

The computing device 200 may provide its output via the output device1804 which may be, e.g., a monitor or other type of display device, aspeaker, or a printer.

The computing device 200, through the network interface 205, may operatein a networked or distributed environment using logical connections toone or more other computing devices, which may be a personal computer, aserver, a router, a network PC, a peer device, a smart phone, or anyother media consumption or transmission device, and may include any orall of the elements described above. The logical connections may includea network (e.g., the network 1750) and/or buses. The network interface205 may be configured to allow the computing device 200 to transmit andreceive data in a network, for example, the network 1750. The networkinterface 205 may include one or more network interface cards (NICs).

FIG. 19 illustrates an example high level block diagram of the datamanagement server 1712 according to one embodiment of the presentinvention. The data management server 1712 may be implemented by thecomputing device 200, and may have a processing unit 1121, a systemmemory 1122, an input device 1123, an output device 1124, and a networkinterface 1125, coupled to each other via a system bus 1126. The systemmemory 1122 may store a data management controller 1712 a and/or a datacollection controller 1712 b.

In one implementation, the data management controller 1712 a may be aJava application. A sponsor user may design a study (e.g., a clinicalstudy) via the data management controller 1712 a and store the studydesign as definition objects in a repository (e.g., 1711 a). A studydesign may have multiple elements, including a casebook, groups, events(e.g., subject visits), and forms which include sections, item groups,items, and fields to be filled out.

In one example, a trial is designed to evaluate subject response to ablood pressure medication. Participants on the medication may visit atrial site three times a week for consecutive six weeks. A workflow maybe designed for each visit, and may include forms to be filled out, andmeasurements to be taken. In one example, a participant's blood pressuremay be measured three times during each visit, stored in the datastorage system (e.g., the repository 1711 b) as trial source data, andsynchronized with other repositories in the data storage system 1711(e.g., the repository 1711 a for the sponsor). In one implementation,only aggregated and obfuscated data, without subject defininginformation, are sent to the sponsor repository 1711 a and stored thereas the EDC data.

A study design may have its own lifecycle. Once a sponsor completes astudy design, a workflow may be executed to publish the study design tothe participating trial sites (e.g., by storing the study design intrial site repositories 1711 b and 1711 c) and the trial may enter itsexecution stage. If the study design is amended during the executionstage, the updates may be sent to the participating trial sites (e.g.,by synchronizing the updates down to the trial site repositories 1711 band 1711 c) for them to follow.

FIGS. 20a to 20e illustrate example user interfaces for creating orediting a study design according to one embodiment of the presentinvention. As shown, in response to a user input, the data managementcontroller 1712 a may present a user interface 400 in FIG. 20a forcreating a new study, study group or organization; a user interface 2010in FIG. 20b for creating an event group, event or form; a user interface2020 in FIG. 20c for creating an object; a user interface 430 in FIG.20d for creating an item group; and a user interface 440 shown in FIG.20e for creating a codelist.

The study design may be stored in the data management system 1710 (e.g.,the repository 1711 a) as objects. A few examples of the objects aredescribed below:

1. FORM_DEF

FORM_DEF is the design object for all Forms.

Field Type Description id System Unique identifier for the record nameSystem - Text Name for the record 128 status System - Picklist Activevs. Inactive description Text 255 Description of the Form. help_contentN/A Stored in translation table. Hover text help text for the item.prev_version Object(form_def) Self-Reference record when a version ofthe record is created. Creates duplicate and duplicate points to theoriginal form_status Picklist Defines whether the item is published orin progress or under review - Full list of picklist values contained intable Data Types table. scheduled boolean Boolean on whether the form isscheduled or unscheduled. change_reason Text 255 Reason for change, if achange is made. OID Text 100 ODM Id for loading in via ODM standardspagelayout_xml N/A Defines that there will be a corresponding XML thatdefines the layout of the Form. label N/A Stored in translation tablestudy Object Reference to the study that is the context of the design.(study_v)

2. FORM_DEF_ITEMGROUP_DEF

FORM_DEF_ITEMGROUP_DEF is the design Intersection object between Formand Item Group. It enables the system to understand what Sections shouldappear on a Form that is part of a visit.

Field Type Description id System Unique identifier for the record nameSystem - System generated autonumber Autonumber status System - PicklistActive vs. Inactive parent Parent Object Parent object of intersectionrecord. (Form_Def) child Parent Object Second parent object ofintersection record. (ItemGroup_Def) repeat_max Number Number of times arepeating question can be captured. order_num Number Order number todisplay the Forms when recording an Event change_reason Text 255 Reasonfor change, if a change is made. Trigger logic on object to prevent achange if the status_vdc is published and this field isn't populated ona change. OID Text 100 ODM Id for loading in via ODM standards mandatoryBoolean Defines if the record is mandatory. label N/A Stored intranslation table study Object (study_v) Reference to the study that isthe context of the design. casebook_def Object Reference to the versionof the Casebook_Def. (casebook_def)

3. EVENT_DEF

EVENT_DEF is the design object for events (visits). A visit will requirethat multiple forms be filled out.

Field Type Description id System Unique identifier for the record nameSystem - Text Name for the record 128 status System - Picklist Activevs. Inactive description Text 255 Description of the Event event_statuspicklist Defines whether the item is published or in progress or underreview - Full list of picklist values contained in table Data Typestable. help_content N/A Stored in translation table. Hover text helptext for the item. event_type picklist Type of event - Baseline, Visit1, etc. repeat_max number Number of times that an event can be repeated.Can be used for unscheduled events and putting a cap on the number ofthese. prev_version Object(event_def) Self-Reference record when aversion of the record is created. Creates duplicate and duplicate pointsto the original scheduled boolean Boolean on whether the event isscheduled or unscheduled. change_reason Text 255 Reason for change, if achange is made. Trigger logic on object to prevent a change if thestatus_vdc is published and this field isn't populated on a change. OIDText 100 ODM Id for loading in via ODM standards label N/A Stored intranslation table study Object (study_v) Reference to the study that isthe context of the design.

4. EVENT_DEF_FORM_DEF

It is the Design Intersection object between Event and Form, and enablesthe system to understand what Forms should appear on a visit.

Field Type Description id System Unique identifier for the record nameSystem - System generated autonumber Autonumber status System - PicklistActive vs. Inactive parent Parent Object Parent object of intersectionrecord. (Event_Def) child Parent Object Second parent object ofintersection record. (Form_Def) change_reason Text 255 Reason forchange, if a change is made. Trigger logic on object to prevent a changeif the status_vdc is published and this field isn't populated on achange. label N/A Stored in translation table OID Text 100 ODM Id forloading in via ODM standards mandatory Boolean Defines if the record ismandatory. order_num Number Order number to display the Forms whenrecording an Event repeat_max Number The limit that the form can berepeated for this event. Null if there is no max. study Object (study_v)Reference to the study that is the context of the design. casebook_defObject Reference to the version of the Casebook_Def. (casebook_def)

5. CASEBOOK_DEF

It is the design object for casebook, which is a set of visits that areexpected to be used to collect information for a specific subject.

Field Type Description id System Unique identifier for the record nameSystem - Text 128 Name for the record status System - Picklist Activevs. Inactive description Text 255 Description of the Eventcasebook_status picklist Defines whether the item is published or inprogress or under review - Full list of picklist values contained intable Data Types table. help_content N/A Stored in translation table.Hover text help text for the item. casebook_type picklist Type ofcasebook prev_version Object(casebook_def) Self-Reference record when aversion of the record is created. Creates duplicate and duplicate pointsto the original change_reason Text 255 Reason for change, if a change ismade. Trigger logic on object to prevent a change if the status_vdc ispublished and this field isn't populated on a change. OID Text 100 ODMId for loading in via ODM standards label N/A Stored in translationtable study Object (study_v) Reference to the study that is the contextof the design.

6. ITEM_[STUDYID]

It is the execution object. Stores the data that is captured. A separateITEM Table will be created per Study.

Field Type Description id System Unique identifier for the record nameSystem - Text 128 Name for the record. Copied from Item_Def. statusSystem - Picklist Active vs. Inactive itemgoup Parent Object (Itemgroup)Parent record item_def Object (Item_def) Relationship to the designrecord value Text 1500 Captured value value_translated Text 1500Translated value of the value codelist_items_defObject(codelist_items_def) Reference to the design record for a selectedcodelist item. codelist_code Text 100 Codelist code that was selectedcodelist_label Text 255 Codelist label (display) that was selectedunit_ref Text 100 Units Reference - Base Unit for translated valueunit_value Text 100 Units Value - Unit that was selected rev_sdv BooleanReview for SDV rev_sdr Boolean Review for SDR rev_dmr Boolean Review forDMR rev_sign Boolean Review for Signature rev_frozen Boolean Review forFrozen rev_locked Boolean Review for Locked change_reason Text 255Reason for change, if a change is made. Trigger logic on object toprevent a change if the status_vdc is published and this field isn'tpopulated on a change. study Object (Study_v) Relationship to Studyrecord. Copied down for performance and query execution. subject Object(Subject) Relationship to Subject record. Copied down for performanceand query execution. site Object (Site_v) Relationship to Site record.Copied down for performance and query execution casebook Object(CaseBook_vdc) Relationship to the Casebook record. Copied down forperformance and query execution. item_status Picklist Current status ofthe Item - completed, in progress, reviewed, verified

7. ITEMGROUP

It is the execution object, and stores that a question was answered in aparticular section (ItemGroup) and the section has a status.

Field Type Description id System Unique identifier for the record nameSystem - Text 128 Name of the record. Copied from ItemGroup_Def. statusSystem - Picklist Active vs. Inactive itemgroup_status picklist Currentstatus of the ItemGroup - completed, in progress, reviewed, verifiedform Parent Object Parent record (Form) itemgroup_seq Number Sequence ofthe Item Group in the case that it repeated itemgroup_def ObjectRelationship to the design record (Itemgroup_def) repeat_key Text Thisis a unique identifier for a repeating item group within a form(generally a table). This is related to both itemgroup_seq_vdc andexternal ID. rev_sdv Boolean Review for SDV. System maintained fieldthat is the aggregate of all of the Items in the Item Group. rev_sdrBoolean Review for SDR. System maintained field that is the aggregate ofall of the Items in the Item Group. rev_dmr Boolean Review for DMR.System maintained field that is the aggregate of all of the Items in theItem Group. rev_sign Boolean Review for Signature. System maintainedfield that is the aggregate of all of the Items in the Item Group.rev_frozen Boolean Review for Frozen. System maintained field that isthe aggregate of all of the Items in the Item Group. rev_locked BooleanReview for Locked. System maintained field that is the aggregate of allof the Items in the Item Group. study Object (Study_v) Relationship toStudy record. Copied down for performance and query execution. subjectObject (Subject) Relationship to Subject record. Copied down forperformance and query execution. site Object (Site_v) Relationship toSite record. Copied down for performance and query execution casebookObject Relationship to the Casebook record. Copied down for(CaseBook_vdc) performance and query execution. change_reason Text 255Reason for change, if a change is made. Trigger logic on object toprevent a change if the status_vdc is published and this field isn'tpopulated on a change.

The objects may be used and transferred across all parts in thearchitecture 1700 shown in FIG. 17, including a sponsor system (e.g.,the data management controller 1712 a and the repository 1711 a), thesites (e.g., the data collection controller 1712 b and the repository1711 b or 1711 c), and the user computing devices 1720 a, 1720 b to 1720n. As will be discussed below with reference to FIG. 23, the userinterfaces in the architecture 1700 may be generated based on theobjects, and data processing and mapping in the architecture 1700 may bebased on correlation of the objects as well.

An example of an item VV-000061 is shown below:

VV-000061 Active

-   -   Created by: John Smith    -   Created date: January 1, 20xx    -   Last Modified by: John Smith    -   Last Modified Date: March 1, 20xx    -   Casebook: SCR-0001    -   Event: VV-000011    -   Form: VV-000021    -   Item Definition: 901-Initials    -   Item Status: Blank    -   Item Group: VV-000023    -   Review for CFR    -   Review for DMR    -   Review for Frozen    -   Review for MMR    -   Review for SDR    -   Review for SDV    -   Review for Signature    -   Subject: SCR-0001    -   Unit Value:    -   Value: NMJ    -   Value Translated        -   Site: 201        -   Study: Vofen        -   Study Country: Vofen        -   Union: VV-000011    -   Review for locked    -   Value Normalized    -   Item Group Definition: Creation Criteria    -   Form Definition: Demographics    -   Event Definition: Screening Visit

The definitions may be correlated and stored in the data storage system1711 as structured data. One example is shown as follows:

Name Event Form Definition Event Definition Item Definition VV-000001VV-000001 Demographics Screening Visit 902-Date of Birth VV-000002VV-000001 Demographics Screening Visit 901-Initials VV-000005 VV-000001Exclusion Criteria Screening Visit 004-Pregnant VV-000009 VV-000001Inclusion Criteria Screening Visit 007-ECG VV-000021 VV-000002 AdverseEvents Common Log Forms AESTDTC

FIG. 21 illustrates an example high level block diagram of a usercomputing device (e.g., 1720 a) wherein the present invention may beimplemented. The user computing device 1720 a may be implemented by thecomputing device 200 described above, and may have a processing unit1201, a system memory 2102, an input device 1203, an output device 1204,and a network interface 1205, coupled to each other via a system bus1206. The system memory 2102 may store the client application 121.

The client application 121 may be an application installed on acomputing device, or a web application. Users at a trial site may entersubject trial information via the client application 121, and the trialsource data may be stored in a repository (e.g., 1711 b).

FIGS. 22a to 22d illustrate example user interfaces for collectingsubject trial information according to one embodiment of the presentinvention. During the execution stage of a trial, when a trial site userlogs into the data management system 1710, a user interface 600 may begenerated based on one or more objects of the definition of the firsttrial and trial source data previously stored in the data storage system1711. The user interface 600 may have an area 601 for displaying trialsthe site user is working on, and an area 2202 for displaying trial taskshe/she needs to take actions on, e.g., overdue forms and queries theyneed to respond to.

When the site user selects a trial from the area 601, a user interface620 shown in FIG. 22b may be displayed, which may have a list of thesubjects of the trial, and their status, including overdue forms and inprogress forms.

When the site user selects a subject, a user interface 640 shown in FIG.22c may be displayed, which may have some biographic information thesubject provided (e.g., date of birth, gender and race), a list of allhis/her visits, and forms that have been filled out. The subjects maycome in on a regular basis, and receive their medication. It may take ameasurement on how they are performing as part of the trial. The datawill be aggregated up to determine if the product is effective and safe.

When the site user starts or selects a visit, a trial form userinterface 660 shown in FIG. 22d may be displayed. The trial site usermay enter data on the trial form user interface 660. For example, basedupon the information just captured, the trial site user may put into thevital forms 98.6° F. for temperature, 72 for height, and 200 for weight.When there is Internet access, the data may be sent to the repository1711 b, and a little icon may show up to indicate that the data isstored in real time. In one embodiment, the trial source data may bechecked for obvious mistakes, e.g., data in a wrong field, and data outof reasonable range. The data validation may be done at the clientapplication 121. Once the site user submits the form, the informationbecomes locked. Alternatively, the data validation may be done at thedata collection controller 1712 b.

The trial site user may navigate through the user interfaces, and go toany point in the hierarchy and any subject in the study. The site usermay fill out the information, and go to the next subject, without havingto change the context and the event in the form that he/she is fillingout.

The user interfaces 600, 620, 640 and 660 may be generated based on oneor more objects in the definition of the first trial. In oneimplementation, the user interfaces may be generated by the datamanagement controller 1712 a, and sent to the trial sites and usercomputing devices. In one implementation, the user interfaces may begenerated by the data collection controller 1712 b based on the objectsin the definition of the first trial from the data management controller1712 a, and sent to the user computing devices. In one implementation,the user interfaces may be generated by the user computing device, e.g.,1720 b, based on the objects in the definition of the first trial fromthe data management controller 1712 a or the data collection controller1712 b.

FIG. 23 illustrates a flowchart of a method for collecting dataaccording to one embodiment of the present invention.

The process may start at 701.

At 703, a user interface, e.g., the user interface 400 shown in FIG. 20a, may be generated for accepting definition of a first study design froma sponsor user. In one implementation, the data management controller1712 a may enable display of the user interface 400 on a sponsor usercomputing device (e.g., 1720 a) for accepting definition of the firststudy design.

At 705, the first study design may be received at the data managementcontroller 1712 a from the user computing device 1720 a and stored inthe data management system 1710, e.g., the repository 1711 a for thesponsor. The first study design may define one or more forms for eachvisit, and each form may include information such as a subject'sdemographic information (e.g., name, Date of Birth, race and gender) andtrial source data to be collected. The first study design may alsodefine events and the sequence of the events, which may includescreening events, enrollment, medical history, repeating frequency ofvisits depending on the protocol, and workflow of each visit (e.g.,administering medication and taking one or more measurements on apredetermined schedule). Each form may have a number of boxes forreceiving data. The definitions, elements or items (e.g., Date of Birth)may be used across the sponsor system, all trial site systems and usercomputing devices, and flow back and forth in the architecture 1700shown in FIG. 17. In one example, the study is to monitor blood pressureresponse to a medication, and may require a number of visits accordingto a predetermined schedule and a blood pressure value for each visit.As discussed above, the first study design may be stored in the datamanagement system 1710 (e.g., the repository 1711 a) as various objects,including FORM_DEF, FORM_DEF_ITEMGROUP_DEF, EVENT_DEF,EVENT_DEF_FORM_DEF, CASEBOOK_DEF, ITEM_[STUDYID] and ITEMGROUP.

At 707, the first study design may be published and transmitted to sitesinvolved. In one implementation, the study design may be stored in,e.g., the repository 1711 b for a first participating site and therepository 1711 c for a second participating site. In one example, therepository 1711 b and the repository 1711 c may be authenticated beforethe first design study can be transmitted to it.

In one implementation, trial forms, e.g., the trial form shown in FIG.22d , may be generated at the data management controller 1712 a based onobjects in definition of the first study design and sent to the trialsite repositories (e.g., 1711 b and 1711 c).

At 709, the first study design may be updated or expanded, e.g., by thedata collection controller 1712 b in the first trial site system. Forexample, the first study definition from the sponsor's data managementcontroller 1712 a may require a blood pressure value, and the object maybe, e.g., 901-Initial. The definition may be updated at the datacollection controller 1712 b to use the average of three blood pressurevalues during one visit as the blood pressure value required by thefirst study definition, and the objects may be 901-Initial-1,901-Initial-2, 901-Initial-3 and 901-Initial-Calculated. Differentversions of definitions may be mapped and correlated.

At 711, a trial site user may log in, and user interfaces 600, 620, 640and 660 may be displayed while he/she is navigating through the webpagesto select the study, subject, event and form. In one implementation, theuser interfaces 600, 620, 640 and 660 may be generated by the datacollection controller 1712 b in the first trial site system based on theupdated objects (e.g., 901-Initial-1, 901-Initial-2, and 901-Initial-3)and data in the data storage system 1711, and sent to the user computingdevice 1720 b. In one implementation, the user interfaces 600, 620, 640and 660 may be generated by the user computing device 1720 b based onthe objects in the first study definition from the data managementcontroller 1712 a (e.g., 901-Initial) or updated objects from the datacollection controller 1712 b (e.g., 901-Initial-1, 901-Initial-2, and901-Initial-3), and data from the data storage system 1711.

At 713, data may be entered on a user interface, e.g., the userinterface 660 shown in FIG. 22d , on the user computing device 1720 b,and stored in the repository 1711 b as trial source data via the datacollection controller 1712 b. Data may also be entered to the usercomputing device 1720 c, and stored in the repository 1711 c as trialsource data via the data collection controller 1712 b. In one example,during execution of the study on a site, a subject's blood pressure maybe taken three times during a visit and stored in the repository 1711 bas trial source data, e.g., 901-Initial-1, 901-Initial-2, and901-Initial-3.

At 715, the trial source data may be processed to get the EDC data. Inone example, the three blood pressure values may be averaged up andobfuscated to get the EDC data. The trial source data from the usercomputing device 1720 b (e.g., 110/70, 106/69, and 111/74) andcorresponding to the updated objects from the data collection controller1712 b (e.g., 901-Initial-1, 901-Initial-2, and 901-Initial-3) may beprocessed to get 901-Initial-Calculated (e.g., 109/71), which may thenbe processed into the EDC data (e.g., through obfuscation. The EDC datamay include the object 901-Initial-Calculated and its value. In oneimplementation, the trial source data may be sent to the data collectioncontroller 1712 b and converted to the EDC data there. Alternatively,the trial source data may be processed on the user computing device 1720b, and the EDC data is then transmitted to the data managementcontroller 1712 a.

At 717, the EDC data may be mapped to the objects in the first studydesign, e.g., the 901-Initial-Calculated may be mapped to the object901-Initial in the definition of the first study design based on theirdefinitions.

At 719, the EDC data may be stored in the repository 1711 a mapped toobjects in the definition of the first study design.

At 721, it may be determined if there are any updates to the first studydesign. If yes, the process may return to 707 for transmitting updatesto the first study design. Otherwise, the process may return to 711 tocapture the data.

In one implementation, JSON formatted structure may be used for the datamapping to allow the data to flow back and forth across various parts inthe architecture 1700.

In some embodiments, a method is provided for providing approved contentfrom a controlled content repository. The method comprises: establishingan access protocol for a controlled content repository, wherein approvedcontent is stored in the controlled content repository and is accessibleaccording to the access protocol, wherein the access protocol is usedfor determining if the approved content in the controlled contentrepository can be used to generate a first electronic user interfaceassociated with a first computing device, and wherein the approvedcontent comprises or is generated based on first data associated with afirst object and second data associated with a second object; receiving,from a second computing device, the first data associated with the firstobject and the second data associated with the second object; providingthe approved content in the controlled content repository to the firstcomputing device after a determination that the approved content in thecontrolled content repository is authorized to be made available to thefirst computing device in accordance with the access protocol, whereinthe first electronic user interface associated with the first computingdevice is generated based on the first data associated with a firstobject and the second data associated with the second object; receiving,from the first computing device, first source data and second sourcedata; aligning or correlating the first source data with the first dataassociated with the first object; and aligning or correlating the secondsource data with the second data associated with the second object. Insome embodiments, the first or second computing device may refer to anycomputing device, system, or apparatus described herein.

In some embodiments, the first data associated with the first objectcomprises at least one of a first definition or a first workflowassociated with the first object.

In some embodiments, the first source data and the second source dataare stored in a source repository separate from the controlled contentrepository. In some embodiments, the controlled content repository mayrefer to any repository, memory, data storage, etc., described herein.

In some embodiments, the first data associated with the first object andthe second data associated with the second object are stored in thesource repository. In some embodiments, the source repository may referto any repository, memory, data storage, etc., described herein.

In some embodiments, the first source data is associated with at leastone of a first subject or a second subject.

In some embodiments, the method further comprises aggregating the firstsource data associated with the at least one of the first subject or thesecond subject.

In some embodiments, the method further comprises obfuscating the firstsource data associated with the at least one of the first subject or thesecond subject to remove subject identification information associatedwith the at least one of the first subject or the second subject.

In some embodiments, the method further comprises initiating storage ofelectronic data capture (EDC) data comprising the aggregated andobfuscated first source data associated with the at least one of thefirst subject or the second subject.

In some embodiments, the method further comprises mapping orcorrelating, using a customized EDC system, the EDC data to the firstobject and the second object.

In some embodiments, the first source data is associated with a firstevent.

In some embodiments, a second electronic user interface associated withthe second computing device is used for generating a definition for thefirst event and a workflow for the first event.

In some embodiments, the first electronic user interface enablesnavigation between the first event and a first subject associated withthe first source data.

In some embodiments, the first event comprises or is part of a firstclinical trial.

In some embodiments, the method further comprises enabling the firstcomputing device to access an updated definition of the first objectprior to the first event.

In some embodiments, the method further comprises extending the firstobject to generate a third object, wherein the third object iscorrelated to the first object, wherein the first electronic userinterface associated with the first computing device is generatedfurther based on the third object.

In some embodiments, the method further comprises validating the firstsource data and the second source data.

In some embodiments, a system is provided for providing approved contentfrom a controlled content repository. The method comprises: a controlledcontent repository for storing approved content, wherein the controlledcontent repository is accessible according to an access protocol,wherein the access protocol comprises at least one set of access rules,wherein the access protocol enables determining if the approved contentwithin the controlled content repository can be made available to afirst computing device via an electronic user interface, wherein theapproved content comprises or is generated based on first dataassociated with a first object and second data associated with a secondobject; and a controlling computing device, in communication with thecontrolled content repository, providing the approved content within thecontrolled content repository to a first computing device after adetermination that the approved content within the controlled contentrepository is authorized to be made available to the first computingdevice in accordance with the access protocol, wherein the electronicuser interface is generated based on first data associated with a firstobject and second data associated with a second object, wherein theelectronic user interface is used for initiating receipt of source dataassociated with a first subject, and wherein the source data is mapped,correlated, or aligned to the first data associated with the firstobject and the second data associated with the second object.

In some embodiments, the system further comprises a specializedelectronic data capture (EDC) system for obfuscating the source data,and mapping, correlating, or aligning the source data to the first dataassociated with the first object and the second data associated with thesecond object.

In some embodiments, another method is provided for providing contentfrom a controlled content repository. The method comprises: establishingan access protocol for a controlled content repository, wherein contentis stored in the controlled content repository and is accessibleaccording to the access protocol, wherein the access protocol is usedfor determining if the content in the controlled content repository canbe used to generate a first electronic user interface associated with afirst computing device, and wherein the content comprises or isgenerated based on first data associated with a first object and seconddata associated with a second object; receiving, from a second computingdevice, the first data associated with the first object and the seconddata associated with the second object; providing the content in thecontrolled content repository to the first computing device after adetermination that the content in the controlled content repository isauthorized to be made available to the first computing device inaccordance with the access protocol, wherein the first electronic userinterface associated with the first computing device is generated basedon the first data associated with a first object and the second dataassociated with the second object; and receiving, from the firstcomputing device, source data, wherein the source data is mapped,aligned, or correlated to the first data associated with the firstobject and the second data associated with the second object.

In some embodiments, the mapping, aligning, or correlating is performedby an EDC component having access to one or more mapping, alignment, orcorrelation rules, respectively, in the controlled content repository.

FIG. 24 illustrates a network system environment 2400 that includes acontrolled content repository system 2402 comprising multiple contentversions according to some embodiments of the present invention. Thecontrolled content repository system 2402 may refer to any computingdevice described in this disclosure. The controlled content repositorysystem 2402 may include rules 2404, first version of content 2406, andsecond version of content 2408, each of which may be stored in the sameor different computer readable media such as memory, hard drives, orother storage spaces, which may be located in the cloud.

The first version of content 2406 may include references (or links,connections, single-directional or multi-directional pointers, etc.)aligned to or pointing to multiple objects. Alignment between an objectand a version of content may include a pointer from the object to theversion of content and/or a pointer from the version of content to theobject. The objects referenced by the first version of content 2406 mayinclude an event group object 2414, an event object 2420, an item groupobject 2426, and an item object 2432. Each of the objects may be relatedto one or more other objects. Other objects 2412, 2418, 2424, 243, 2436,and 2438 are also shown in FIG. 24. As an example, any object connected(e.g., directly connected) to any other object shown in FIG. 24 isrelated to that other object. In some embodiments, the relationshipsamong various objects may be defined using a customized data structuresuch as a customized table, linked list, doubly linked list, queue,heap, tree, B-tree, binary search tree, graph, undirected graph,weighted graph, etc.

The second version of content 2408 may also include references alignedto or pointing to multiple objects. These objects may include an eventgroup object 2416, an event object 2422, an item group object 2428, andan item object 2434. Some of these objects may be the same as thosereferenced by the first version of content 2406, while other objects maybe different from those referenced by the first version of content 2406.As an example, both objects 2414 and 2416 are directly linked to object2412. Therefore, in some embodiments, both objects 2414 and 2416 may bethe same object even though they are represented as different objects inFIG. 24. In other embodiments, both objects 2414 and 2416 are differentobjects that are related to the same object 2412. As another example,the second version of content 2408 may include a reference to an itemgroup object 2434 that includes references to objects 2430 and 2438, butdoes not include a reference to object 2436, which is referenced by theitem group object 2432 referenced by the first version content 2406.Therefore, in some embodiments, both objects 2434 and 2432 are differentobjects. Although not shown, additionally or alternatively, the secondversion of content 2408 may include specific references to modificationsof objects that are referenced by the first version of content 2406along with any objects that not referenced by previous versions ofcontent. Objects may be reused as references across multiple versions ofcontent.

In some embodiments, the various objects described herein may beincluded in a form (e.g., an electronic form) associated with a visit.In other embodiments, the various content versions may be versions of aform that includes the various objects described herein. Content mayrefer to an instantiated study design, which may be associated with atrial as described in this disclosure. In some embodiments, an event mayrefer to a visit associated with a trial. An event group (or eventcontainer) may refer to a set of related events. An item may refer to afield on or a prompt associated with a form. An item group (or itemcontainer) may refer to a set of related items.

In some embodiments, the rules 2404 may be rules, parameters, accessprotocols, etc., associated with accessing, storing, or modifyingspecific versions of content 2406 and/or 2408 or specific objects, suchas a date of birth-related object 2436. The rules 2404 include one ormore subsets such as rule subset 2410. The rules may be associated withcreating a new object, modifying alignment of references connected to anobject, creating a version of content, linking and/or delinking objects,etc. In some embodiments, the rules 2404 may include a set of accessprotocols that determine whether a computing device is permitted orapproved to access any objects or associated data, content or associateddata, measured data, data analysis, settings of the controlled contentrepository system 2402, etc.

When creating the second version of content 2408, objects from the firstversion of content 2406 are not copied over or migrated to the secondversion of content 2408. Additionally, in some embodiments, an object,once published for referencing by a version of content, may not bemodified because previous versions of content may continue to referencethat object. Therefore, new objects or modifications of objects arecreated and referenced by new versions of content. In some alternateembodiments, objects may be modifiable and both previously created(i.e., created before modification of the objects) and newly created(i.e., created after modification of the objects) may reference both themodified and unmodified objects. Any modification to an object asdescribed herein may refer to modification in definition or parametersof that object. In some embodiments, a user may be provided with a deltaanalyzer or viewer to view and analyze differences between versions ofcontent, objects, references to objects, etc., which may be useful forcreating future objects or future versions of content.

In some embodiments, a user may use a software tool to create a newobject or version of content. If the user attempts to input or establisha definition identical to a previously created or published object or aversion of content with objects identical to a previously createdversion of content, the software tool may prevent the user from creatingthe new object or version of content to prevent proliferation ofidentical objects or versions of content. In some embodiments, datavalidation rules and data quality requirements may need to be satisfiedbefore creating a new object or version of content. Once an object iscreated, the object may comprise lineage associated with related objectssuch as those based on which the object is created. Such objects may bereferred to as parent objects. In some embodiments, a new version ofcontent may comprise data associated with design amendments thatindicate differences between the new version of content and previousversions of the content. In some embodiments, any data structuresdescribed herein to store an object and/or content may be modified toaccommodate data associated with object lineage, design amendments, etc.Such data structures include a customized table, linked list, doublylinked list, queue, heap, tree, B-tree, binary search tree, graph,undirected graph, weighted graph, etc.

In some embodiments, a lineage associated with an object may be storedwith or associated with an object in the controlled content repositorysystem 2402. A lineage associated with an object may include objectdefinitions or parameters associated with related objects in a previousversion of content (e.g., created before creation of the presentobject), differences between the present object and related objects in aprevious version of content, software tools that were used to create thepresent object and related objects in a previous version of content,data structures and/or storage devices used for storing the presentobject and other related objects in a previous version of content, etc.In some embodiments, an object may be associated with a standard (e.g. astandard set of parameters or definitions). Tracing the lineage of theobjects enables analysis of deviations from the standard. Therefore, thepresent invention enables synchronization of content and/or objects overa period of time such that changes to the content and/or objects overthe period of time are easy to access, analyze, and build upon.

In some embodiments, an object may be stored in a customized orspecialized data structure. The data structure may be located orsearched by any computing system based on identification information.For example, the identification information may include uniqueidentification information associated with the controlled contentrepository system 2402 (e.g., the system where the data structure iscreated and/or stored) concatenated with unique identificationinformation associated with the object. The identification informationof the object enables tracking or linking back to a related object(e.g., a parent object) associated with the object. A parent object mayrefer to a previous version of the object associated with a previousversion of content. Example data structures include a customized table,linked list, doubly linked list, queue, heap, tree, B-tree, binarysearch tree, graph, undirected graph, weighted graph, etc.

The controlled content repository 2402 system may store both design dataand measured data. Design data may refer to forms for use in trials, andmay refer to content and/or objects as described herein. Measured datamay refer to physical data collected from subjects of trials based onprompts encountered on the forms. One or more rules and/or relationshipparameters may be used to relate the design data to the measured data,or vice versa. The controlled content repository system 2402 may be usedto store design data and/or measured data associated with a singleentity or multiple entities. As used herein, an entity may refer to auser, a customer, a tenant, etc., all of which can be usedinterchangeably.

FIG. 25 illustrates two different electronic data capture (EDC)techniques according to some embodiments of the present invention. InEDC 1, a first version of content 2504 includes objects 2506, 2508,2510, and 2512. When creating the second version of content 2514, theobjects 2506, 2508, 2510, and 2512 are copied over such that the secondversion of content 2514 includes new objects 2516, 2518, 2520, 2522, and2524. In EDC 2, a first version of content 2528 includes references toobjects 2530, 2532, 2534, and 2536. When creating the second version ofcontent 2538, references to the objects 2530, 2532, and 2534, which werepreviously linked or aligned to the first version of content 2528, areadditionally linked or aligned to the second version of content 2538.The links may be at least one of from the objects to the version ofcontent, or from the version of content to the objects. Notably, thesecond version of content 2538 is not linked to the object 2536.Instead, references to new objects 2539 and 2540, or an object groupcomprising objects 2539 and 2540, are linked to the second version ofcontent 2538. In some embodiments, the object 2536 may be linked to newobjects 2539 and 2540, or an object group comprising objects 2539 and2540. Additionally or alternatively, new objects 2539 and 2540, or anobject group comprising objects 2539 and 2540 may include object lineageinformation, which may include data associated with object 2536 becausenew objects 2539 and 2540 were derived from and/or are related to object2536. When creating the second version of content 2538, a controlledcontent repository system that controls and/or stores the variousversions of content does not have to enter a downtime mode (e.g., nopower mode, low power mode, etc.) in order to create the second versionof content 2538. In some embodiments, objects may additionally bede-linked from content versions.

The present invention enables efficient testing and validating of thecontent, and/or the objects referenced by or associated with the contentsuch that information associated with the testing and validation of thecontent and/or objects is readily available or associated with thecontent and/or objects. In some embodiments, the testing and validationinformation may also be stored in the controlled content repositorysystem described herein. Additionally, the present invention enablesobjects and/or forms to be tested and validated such that results of thetesting and validation are available for future objects related to thetested and validated objects and/or future versions of the tested andvalidated forms.

FIG. 26 illustrates a network system environment 2600 that includes acontrolled content repository system 2608 according to some embodimentsof the present invention. In some embodiments, the various systemsand/or units described in this figure are hardware. In otherembodiments, the various systems and/or units described in this figureare software. In still other embodiments, the various systems and/orunits described in this figure are a combination of hardware and/orsoftware. The network system environment 2600 includes a controlledcontent repository system 2608, a first computing device 2602, and asecond computing device 2604. The three systems are shown as beingdisparately located from each other. In some embodiments, any of thesystems may be comprised in or comprise any of the other systems. Insome embodiments, the first computing device 2602 may be any portable ornon-portable computing device such as a desktop or laptop computer,tablet, mobile phone, wearable device, etc., located at a clinic where atrial is conducted. In some embodiments, the second computing device2604 may be any portable or non-portable computing device such as adesktop or laptop computer, tablet, mobile phone, wearable device, etc.,associated with an entity (e.g., a pharmaceutical entity) associatedwith or commissioning the trial.

The controlled content repository system 2608 may include a processingsystem 2634, a memory system 2620, an input/output (I/O) system 2646,and a communication system 2610. The inclusion of each system in thecontrolled content repository system 2608 is optional. Each of theprocessing system 2634, the memory system 2620, the input/output (I/O)system 2646, and the communication system 2610 may include one or moreunits for performing any operation, technique, method, process, etc.,described herein. Further, each system and/or unit of the controlledcontent repository system 2608 may be operatively and/or otherwisecommunicatively coupled with each other so as to perform any operation,technique, method, process, etc., described herein. The controlledcontent repository system 2608 including any of its systems and/or unitsmay include general hardware, specifically-purposed hardware, and/orsoftware. The controlled content repository system 2608 may include oneor more co-located or disparately located computing systems for storingthe various systems illustrated as being included in the controlledcontent repository system 2608.

The processing system 2634 may control one or more of the memory system2620, the input/output (I/O) system 2646, and the communication system2610, as well as any included units, elements, components, devices,and/or functions performed by the memory system 2620, the input/output(I/O) system 2646, and the communication system 2610. Any actionsdescribed herein as being performed by a processor or signal processormay be taken as being performed by the processing system 2634 aloneand/or by the processing system 2634 in conjunction with one or moreadditional processing systems, processors, units, elements, components,devices, and/or the like. Additionally, while one processing system 2634may be shown, multiple processing systems may be present and/orotherwise included in the controlled content repository system 2608 orelsewhere in the overall network system environment 2600. Thus, whileinstructions may be described as being executed by the processing system2634 (and/or various units of the processing system 2634), theinstructions may be executed simultaneously, serially, and/or otherwiseby one or multiple processing systems on one or more devices.

In some embodiments, the processing system 2634 may be implemented asone or more computer or central processing unit (CPU) chips and/orgraphical processing unit (GPU) chips and may include a hardware devicecapable of executing computer instructions. The processing system 2634may execute instructions, codes, computer programs, and/or scripts. Theinstructions, codes, computer programs, and/or scripts may be receivedfrom and/or stored in the memory system 2620, the I/O system 2646, thecommunication system 2610, units and/or elements of the aforementionedunits, other devices and/or computing environments, and/or the like.

In some embodiments, the processing system 2634 may include, among otherelements, units such as a central processor 2636 which may be a centralprocessing unit (CPU) 2636, a system management unit 2638 and a resourceallocation unit 2640. Each of the units of the processing system 2634may be communicatively and/or otherwise operably coupled with eachother. The central processor 2636 refers to electronic circuitry thatcarries out instructions of a computer program, including logical,control, arithmetic, and input/output (I/O) instructions. The systemmanagement unit 2638 refers to hardware and/or software that coordinatesoperations of the processing system 2634 with operations of thecommunication system 2610, the memory system 2620, and the I/O system2646.

The resource allocation unit 2640 may facilitate the determination,monitoring, analysis, and/or allocation of computing resourcesthroughout the controlled content repository system 2608 and/or othercomputing environments. As such, computing resources of the controlledcontent repository system 2608 utilized by the processing system 2634,the memory system 2620, the input/output (I/O) system 2646, and thecommunication system 2610 (and/or any unit of the aforementionedsystems) such as processing power, data storage space, networkbandwidth, and/or the like may be in high demand at various times duringoperation. Accordingly, the resource allocation unit 2640 may beconfigured to manage the allocation of various computing resources asthey are required by particular systems and/or units of the controlledcontent repository system 2608 and/or other computing environments. Insome embodiments, the resource allocation unit 2640 may include sensorsand/or other specially-purposed hardware for monitoring performance ofeach system of the controlled content repository system 2608, as well ashardware for responding to the computing resource needs of each unit. Insome embodiments, the resource allocation unit 2640 may utilizecomputing resources of a second computing environment separate anddistinct from the controlled content repository system 2608 tofacilitate a desired operation such as creating a new object, modifyingreferences connected to an object, creating a version of content, etc.The resource allocation unit 2640 may retrieve, transmit, control,allocate, and/or otherwise distribute determined amount(s) of computingresources to each system and/or unit of the controlled contentrepository system 2608. In some embodiments, the allocation of computingresources of the resource allocation unit 2640 may include the resourceallocation unit 2640 flipping a switch, adjusting processing power,adjusting memory size, partitioning a memory element, transmitting data,controlling one or more input and/or output devices, modifying variouscommunication protocols, and/or the like.

In some embodiments, the memory system 2620 may be utilized for storing,recalling, receiving, transmitting, and/or accessing object-related dataand/or content-related data and/or measured data during operation of thecontrolled content repository system 2608. For example, the memorysystem 2620 may be utilized for storing recalling, and/or updatingobject-related data and/or content-related data and/or measured dataand/or the like. The memory system 2620 may include various types ofdata storage media such as solid state storage media, hard disk storagemedia, virtual storage media, and/or the like. The memory system 2620may include dedicated hardware elements such as hard drives and/orservers, as well as software elements such as cloud-based storagedrives. For example, the memory system 2620 may include various unitssuch as an operating system unit 2626, an application data unit 2628, anapplication programming interface (API) unit 2630, a system storage unit2624, a secure enclave 2632, and/or a cache storage unit 2622. In someembodiments, any of these units may be customized with code forperforming the various operations described herein.

The memory system 2620 and/or any of its units described herein mayinclude random access memory (RAM), read only memory (ROM), and/orvarious forms of secondary storage. RAM may be used to store volatiledata and/or to store instructions that may be executed by the processingsystem 2634. For example, the data stored may be a command, a currentoperating state of the controlled content repository system 2608, anintended operating state of the controlled content repository system2608, and/or the like. As a further example, data stored in the memorysystem 2620 may include instructions related to various methods and/orfunctionalities described herein. ROM may be a non-volatile memorydevice that may have a smaller memory capacity than the memory capacityof a secondary storage. ROM may be used to store instructions and/ordata that may be read during execution of computer instructions. In someembodiments, access to both RAM and ROM may be faster than access tosecondary storage. Secondary storage may be comprised of one or moredisk drives and/or tape drives and may be used for non-volatile storageof data or as an over-flow data storage device if RAM is not largeenough to hold all working data. Secondary storage may be used to storeprograms that may be loaded into RAM when such programs are selected forexecution. In some embodiments, the memory system 2620 may include oneor more databases for storing any data such as object-related dataand/or content-related data and/or measured data and/or the like.Additionally or alternatively, one or more secondary databases locatedremotely from the controlled content repository system 2608 may beutilized and/or accessed by the memory system 2620.

The operating system unit 2626 may facilitate deployment, storage,access, execution, and/or utilization of an operating system utilized bythe controlled content repository system 2608 and/or any other computingenvironment described herein. In some embodiments, the operating systemunit 2626 may include various hardware and/or software elements thatserve as a structural framework for the processing system 2634 toexecute various operations described herein. The operating system unit2626 may further store various pieces of information and/or dataassociated with operation of the operating system and/or the controlledcontent repository system 2608 as a whole, such as a status of computingresources (e.g., processing power, memory availability, resourceutilization, and/or the like), runtime information, modules to directexecution of operations described herein, user permissions, securitycredentials, and/or the like.

The application data unit 2628 may facilitate deployment, storage,access, execution, and/or utilization of an application utilized by thecontrolled content repository system 2608 and/or any other computingenvironment described herein. For example, an application may beassociated with creating a new object, creating a new version ofcontent, associating or aligning a version of content with variousobjects, analyzing the measured data with respect to objects associatedwith a version of content, setting an access protocol for providing datato computing devices from the controlled content repository system 2608,etc. As such, the application data unit 2628 may store any informationand/or data associated with the application. A user may use informationincluded in the application data unit 2628 to execute various operationsdescribed herein. The application data unit 2628 may further storevarious pieces of data associated with operation of the applicationand/or the controlled content repository system 2608 as a whole, such asa status of computing resources (e.g., processing power, memoryavailability, resource utilization, and/or the like), runtimeinformation, user interfaces, modules to direct execution of operationsdescribed herein, user permissions, security credentials, accessprotocols, and/or the like.

The application programming interface (API) unit 2630 may facilitatedeployment, storage, access, execution, and/or utilization ofinformation associated with APIs of the controlled content repositorysystem 2608 and/or any other computing environment described herein. Forexample, the controlled content repository system 2630 may include oneor more APIs for various devices, applications, units, elements tocommunicate with each other and/or utilize the same data. Accordingly,the API unit 2630 may include API databases comprising information(e.g., associated with object-related data and/or content-related dataand/or measured data and/or the like) that may be accessed and/orutilized by applications, units, elements, and/or operating systems ofdevices and/or computing environments. In some embodiments, each APIdatabase may be associated with a customized physical circuit includedin the memory system 2620 and/or the API unit 2630. Additionally, eachAPI database may be public and/or private, and so authenticationcredentials associated with one or more access protocols may be requiredto access information in an API database.

The system storage unit 2624 may facilitate deployment, storage, access,and/or utilization of object-related data and/or content-related dataand/or measured data and/or the like by the controlled contentrepository system 2608 and/or any other computing environment describedherein. In some embodiments, the system storage unit 2624 maycommunicate with the system management unit 2638 to receive and/ortransmit object-related data and/or content-related data and/or measureddata and/or the like.

The secure enclave 2632 may facilitate secure storage of data. In someembodiments, the secure enclave 2632 may include a partitioned portionof storage media included in the memory system 2620 that is protected byvarious security measures, which may also be part of the accessprotocols. For example, the secure enclave 2632 may be hardware secured.In other embodiments, the secure enclave 2632 may include one or morefirewalls, encryption mechanisms, and/or other security-based protocols.Authentication credentials of a user or system may be required prior toproviding access to data stored within the secure enclave 2632. Datastored in the secure enclave 2632 may include any object-related dataand/or content-related data and/or measured data and/or the like.

The cache unit 2622 may facilitate short-term deployment, storage,access, analysis, and/or utilization of data. For example, the cacheunit 2622 may be utilized for storing any object-related data and/orcontent-related data and/or measured data and/or the like. In someembodiments, the cache unit 2622 may serve as a short-term storagelocation for data so that the data stored in the cache unit 2622 may beaccessed quickly. In some embodiments, the cache unit 2622 may includeRAM and/or other storage media types for quick recall of stored data.The cache unit 2622 may include a partitioned portion of storage mediaincluded in the memory system 2620.

The I/O system 2646 may include hardware and/or software elements forthe controlled content repository system 2608 to receive, transmit,and/or present data (object-related data and/or content-related dataand/or measured data and/or the like) useful for performing variousoperations described herein. For example, elements of the I/O system2646 may be used to receive user input from a user via a user device,generate graphical representations of data, present user interfaces anddisplay data to users on the user interface, and/or the like. The userinterfaces may be configured and adjusted for a display device. In thismanner, the controlled content repository system 2608 may use the I/Osystem 2646 to interface with a human (or nonhuman) user. As describedherein, the I/O system 2646 may include units such as an I/O device2648, an I/O calibration unit 2650, and/or a software driver 2652. Thesoftware driver 2652 may comprise a display driver such as a graphicdriver. In some embodiments, the software driver 2652 may comprise aspecialized or customized non-generic driver for specifically performingany particular operation described in this disclosure.

The I/O device 2648 may facilitate the receipt, transmission,processing, presentation, display, input, and/or output of data as aresult of executed operations described herein. In some embodiments, theI/O device 2648 may include a plurality of I/O devices. In someembodiments, the I/O device 2648 may include one or more elements of auser device, a computing system, a server, a remote or local terminal,and/or a similar device. As such, the I/O device 2648 may include avariety of elements for a user to interface with the controlled contentrepository system 2608. For example, the I/O device 2648 may include akeyboard, a touchscreen, a button, a sensor, a biometric scanner, alaser, a microphone, a camera, a barcode scanner, a cash register, apoint-of-sale terminal, and/or another element for receiving and/orcollecting input from a user. Additionally and/or alternatively, the I/Odevice 2648 may include a display, a screen, a sensor, a vibrationmechanism, a light emitting diode (LED), a speaker, a scanner, and/oranother element for presenting and/or otherwise outputting data to auser or to another system. In some embodiments, the I/O device 2648 maycommunicate with one or more elements of the processing system 2634and/or the memory system 2620 to execute operations described herein.

The I/O calibration unit 2650 may facilitate the calibration of the I/Odevice 2648. For example, the I/O calibration unit 2650 may detectand/or determine one or more settings of the I/O device 2648, and thenadjust and/or modify settings so that the I/O device 2648 may operatemore efficiently. For example, the I/O calibration unit 2650 maycalibrate display of data on the I/O device 2648 based on display andsystem settings of the I/O device 2648.

In some embodiments, the I/O calibration unit 2650 may utilize a driver2652 (or multiple drivers) to calibrate the I/O device 2648. Forexample, the driver 2652 may include software that is to be installed bythe I/O calibration unit 2650 so that an element of the controlledcontent repository system 2608 (or an element of the computingenvironment 2600) may recognize and/or integrate with the I/O device2648 for the various operations described herein.

The communication system 2610 may facilitate establishment, maintenance,monitoring, and/or termination of communications between the controlledcontent repository system 2608 and other computing environments, thirdparty server systems, and/or the like. In some embodiments, thecommunication system 2610 may also be referred to as a signal interface.The communication system 2610 may facilitate communication betweenvarious systems and/or units of the controlled content repository system2608. In some embodiments, the communication system 2610 may include anetwork protocol layer 2614, an API gateway 2612, an encryption engine2618, and/or a physical layer circuit 2616. The communication system2610 may include hardware and/or software elements.

The network protocol layer 2614 may facilitate establishment,maintenance, and/or termination of a communication connection for thecontrolled content repository system 2608 by way of a network. Forexample, the network protocol layer 2614 may detect and/or define acommunication protocol required by a particular network and/or networktype. Communication protocols utilized by the network protocol layer2614 may include Wi-Fi protocols, Li-Fi protocols, cellular data networkprotocols, Bluetooth® protocols, WiMAX protocols, Ethernet protocols,powerline communication (PLC) protocols, and/or the like. In someembodiments, facilitation of communication for the controlled contentrepository system 2608 may include transforming and/or translating datafrom being compatible with a first communication protocol (e.g.,associated with a first system such as system 2602 or 2604) to beingcompatible with a second communication protocol (e.g., associated with asecond system such as system 2604 or 2602, respectively). In someembodiments, the network protocol layer 2614 may determine and/ormonitor an amount of data traffic to consequently determine whichparticular network protocol is to be used for establishing a securecommunication connection, transmitting data, and/or performingoperations as described herein.

The API gateway 2612 may facilitate other devices and/or computingenvironments to access the API unit 2630 of the memory system 2620 ofthe controlled content repository system 2608. For example, a usercomputing device may access the API unit 2630 of the controlled contentrepository system 2608 via the API gateway 2612. In some embodiments,the API gateway 2612 may be required to validate user credentials and/orsystem credentials, according to one or more access protocols, prior toproviding access to the API unit 2630 to a user and/or a system. The APIgateway 2612 may include instructions for the controlled contentrepository system 2608 to communicate with another device and/or betweenelements of the controlled content repository system 2608.

The encryption engine 2618 may facilitate translation, encryption,encoding, decryption, and/or decoding of data received, transmitted,and/or stored by the controlled content repository system 2608. Usingthe encryption engine, each transmission of data may be encrypted,encoded, and/or translated for security reasons according to any accessprotocols, and any received data may be encrypted, encoded, and/ortranslated prior to its processing and/or storage. In some embodiments,the encryption engine 2618 may generate an encryption/decryption key,and/or the like, which may be transmitted along with any data content.

The physical layer circuit 2616 may include a variety of communicationhardware and/or software specifically purposed for the controlledcontent repository system 2608. In some embodiments, the physical layercircuit 2616 may include one or more radio transceivers, chips, analogfront end (AFE) units, antennas, processing units, memory, other logic,and/or other components to implement communication protocols (wired orwireless) and related functionality for facilitating communication to orfrom the controlled content repository system 2608. Additionally and/oralternatively, the physical layer circuit 2616 may include a modem, amodem bank, an Ethernet device such as a router or switch, a universalserial bus (USB) interface device, a serial interface, a token ringdevice, a fiber distributed data interface (FDDI) device, a wirelesslocal area network (WLAN) device and/or device component, a radiotransceiver device such as code division multiple access (CDMA) device,a global system for mobile communications (GSM) radio transceiverdevice, a universal mobile telecommunications system (UMTS) radiotransceiver device, a long term evolution (LTE) radio transceiverdevice, a worldwide interoperability for microwave access (WiMAX)device, and/or another device used for communication purposes.

In some embodiments, the processing system 2634 may be connected to datastorage 2642 comprising measured data and/or data storage 2644comprising design content (e.g., any content-related data). The datastorages 2642 and 2644 may be any type of data storage described hereinfor storing specialized non-generic data structures, including datastructures that can concatenate disparate data associated with objects,measured data, content, the controlled repository system 2608, etc. Anyfeatures associated with this description may be combined with anyfeature described in this disclosure. In some embodiments, the datastorages 2642 and 2644 may additionally be protected by an accessprotocol such that the access protocol determines whether computingdevices can access data comprised in the data storages 2642 and 2644.Example data structures include a customized table, linked list, doublylinked list, queue, heap, tree, B-tree, binary search tree, graph,undirected graph, weighted graph, etc.

In some embodiments, a method is provided for providing versions ofcontent from a controlled content repository system. The methodcomprises: establishing, using one or more computing device processors,an access protocol for a controlled content repository system, whereincontent is stored in the controlled content repository system and isaccessible according to the access protocol, wherein the contentcomprises a first version of the content, wherein the access protocol isused for determining if the first version of the content in thecontrolled content repository system can be made available to a firstcomputing device, and wherein the first version of the content comprisesa first reference aligned from the first version of the content to afirst object stored in the controlled content repository system, and asecond reference aligned from the first version of the content to asecond object stored in the controlled content repository system;generating, using the one or more computing device processors, a secondversion of the content, wherein generating the second version of thecontent comprises: aligning, using the one or more computing deviceprocessors, a second reference from the second version of the content tothe first object, and aligning, using the one or more computing deviceprocessors, a third reference from the second version of the content toa third object stored in the controlled content repository system; andproviding, using the one or more computing device processors, the secondversion of the content in the controlled content repository system to asecond computing device after a determination that the content in thecontrolled content repository system is authorized to be made availableto the second computing device in accordance with the access protocol,wherein the second version of the content is created without migratingobjects from the first version of the content to the second version ofthe content.

In some embodiments, the first object, the second object, or the thirdobject comprises at least one of an event group, an event, an itemgroup, or an item. In some embodiments, the first object, the secondobject, or the third object comprises a relationship object. In someembodiments, the content comprises an instantiated study design. In someembodiments, the instantiated study design is associated with a trial.

In some embodiments, the first object comprises an unmodifiable object.In some embodiments, the first object becomes unmodifiable when thefirst object is published for association with the first version of thecontent. In some embodiments, the first object comprises a modifiableobject.

In some embodiments, the method further comprises providing a deltaanalyzer for enabling view of at least one difference between the firstversion of the content and the second version of the content. In someembodiments, the second version of the content is created without thecontrolled content repository system entering a downtime mode.

In some embodiments, the first object is stored in a customized datastructure. In some embodiments, the customized data structure comprisesidentification information concatenated based on first identificationinformation associated with the controlled content repository system andsecond identification information associated with the first object.

In some embodiments, the first object comprises a lineage of the firstobject. In some embodiments, the method further comprises tracking andstoring the lineage of the first object. In some embodiments, the methodfurther comprises analyzing, based on the lineage of the first object,how a standard associated with the first object deviated over time.

In some embodiments, the content comprises study design content. In someembodiments, the content further comprises clinical data content. Insome embodiments, the method further comprises establishing at least onerelationship parameter between the study design content and the clinicaldata content. In some embodiments, the method further comprises aligningthe clinical data content to the study design content.

In some embodiments, the method further comprises applying rulesassociated with the first version of the content to the second versionof the content. In some embodiments, the rules comprise validationrules.

In some embodiments, the method further comprises preventing creation ofa fourth object in response to determining the fourth objectsubstantially matches at least one of the first object, the secondobject, or the third object. In some embodiments, the first object is afirst version of the first object, and the second object is a secondversion of the first object. In some embodiments, the first object isassociated with first rules, and wherein the second object is associatedwith second rules different from the first rules.

In some embodiments, a controlled content repository system is providedfor providing versions of content. The controlled content repositorysystem comprises: a communication system comprising a network protocollayer and a physical layer circuit, the communication system fortransmitting or receiving data from computing devices; a memory systemcomprising an operating system and an application programming interface(API), the memory comprising code for performing one or more operations;and a processing system comprising a central processing unit (CPU), theprocessing system for performing the one or more operations comprising:establishing an access protocol for the controlled content repositorysystem, wherein content is accessible according to the access protocol,wherein the content comprises a first version of the content, whereinthe access protocol is used for determining if the first version of thecontent in the controlled content repository system can be madeavailable to a first computing device, and wherein the first version ofthe content comprises a first reference aligned from the first versionof the content to a first object stored in the controlled contentrepository system, and a second reference aligned from the first versionof the content to a second object stored in the controlled contentrepository system; generating a second version of the content, whereingenerating the second version of the content comprises: generating asecond reference aligned from the second version of the content to thefirst object, and generating a third reference aligned from the secondversion of the content to a third object stored in the controlledcontent repository system; and providing the second version of thecontent in the controlled content repository system to a secondcomputing device after a determination that the content in thecontrolled content repository system is authorized to be made availableto the second computing device in accordance with the access protocol,wherein the second version of the content is created without copyingobjects from the first version of the content to the second version ofthe content.

In some embodiments, another method is provided for providing versionsof content from a controlled content repository system. The methodcomprises: establishing, using one or more computing device processors,an access protocol for a controlled content repository system, whereincontent is stored in the controlled content repository system and isaccessible according to the access protocol, wherein the contentcomprises a first version of the content, wherein the access protocol isused for determining if the first version of the content in thecontrolled content repository system can be made available to a firstcomputing device, and wherein the first version of the content comprisesa first reference aligned from the first version of the content to afirst object stored in the controlled content repository system, and asecond reference aligned from the first version of the content to asecond object stored in the controlled content repository system;generating, using the one or more computing device processors, a secondversion of the content, wherein generating the second version of thecontent comprises: aligning, using the one or more computing deviceprocessors, a second reference from the second version of the content tothe first object, and aligning, using the one or more computing deviceprocessors, a third reference from the second version of the content toa delta associated with the first object stored in the controlledcontent repository system; and providing, using the one or morecomputing device processors, the second version of the content in thecontrolled content repository system to a second computing device aftera determination that the content in the controlled content repositorysystem is authorized to be made available to the second computing devicein accordance with the access protocol. In some embodiments, anon-transitory computer readable medium is provided that stores code forperforming any of the operations described in this disclosure.

This application is a continuation-in-part of U.S. application Ser. No.14/611,012, filed on Jan. 30, 2015, which is a continuation-in-part ofU.S. application Ser. No. 14/271,134, filed on May 6, 2014, which claimspriority to U.S. Provisional Patent Application Nos. 61/820,029, filedMay 6, 2013, and 61/828,034, filed May 28, 2013, all of which are herebyincorporated by reference herein for all purposes.

This application incorporates by reference U.S. application Ser. No.14/558,432, filed on Dec. 2, 2014, which is a continuation-in-part ofU.S. application Ser. No. 14/271,134, filed on May 6, 2014, which claimspriority to U.S. Provisional Patent Application Nos. 61/820,029, filedMay 6, 2013, and 61/828,034, filed May 28, 2013, all of which are herebyincorporated by reference herein for all purposes.

This application incorporates by reference U.S. application Ser. No.14/613,293, filed on Feb. 3, 2015, which is a continuation-in-part ofU.S. application Ser. No. 14/271,134, filed on May 6, 2014, which claimspriority to U.S. Provisional Patent Application Nos. 61/820,029, filedMay 6, 2013, and 61/828,034, filed May 28, 2013, all of which are herebyincorporated by reference herein for all purposes.

This application incorporates by reference U.S. application Ser. No.14/699,553, filed on Apr. 29, 2015, which is a continuation of U.S.application Ser. No. 14/271,134, filed on May 6, 2014, which claimspriority to U.S. Provisional Patent Application Nos. 61/820,029, filedMay 6, 2013, and 61/828,034, filed May 28, 2013, all of which are herebyincorporated by reference herein for all purposes.

This application is a continuation-in-part of U.S. application Ser. No.15/629,587, filed on Jun. 21, 2017, which claims priority to U.S.Provisional Patent Application No. 62/407,399, filed on Oct. 12, 2016,which is hereby incorporated by reference herein for all purposes.

This application is a continuation-in-part of U.S. application Ser. No.14/819,371, filed on Aug. 5, 2015, which is a continuation-in-part ofU.S. application Ser. No. 14/702,307, filed on May 1, 2015, both ofwhich are hereby incorporated by reference herein for all purposes.

The above-described features and applications can be implemented assoftware processes that are specified as a set of instructions recordedon a computer readable storage medium (also referred to as computerreadable medium). When these instructions are executed by one or moreprocessing unit(s) (e.g., one or more processors, cores of processors,or other processing units), they cause the processing unit(s) to performthe actions indicated in the instructions. Examples of computer readablemedia include, but are not limited to, CD-ROMs, flash drives, RAM chips,hard drives, EPROMs, etc. The computer readable media does not includecarrier waves and electronic signals passing wirelessly or over wiredconnections.

These functions described above can be implemented in digital electroniccircuitry, in computer software, firmware or hardware. The techniquescan be implemented using one or more computer program products.Programmable processors and computers can be included in or packaged asmobile devices. The processes and logic flows can be performed by one ormore programmable processors and by one or more programmable logiccircuitry. General and special purpose computing devices and storagedevices can be interconnected through communication networks.

In this specification, the term “software” is meant to include firmwareresiding in read-only memory or applications stored in magnetic storage,which can be read into memory for processing by a processor. Also, insome implementations, multiple software technologies can be implementedas sub-parts of a larger program while remaining distinct softwaretechnologies. In some implementations, multiple software technologiescan also be implemented as separate programs. Finally, any combinationof separate programs that together implement a software technologydescribed here is within the scope of the subject technology. In someimplementations, the software programs, when installed to operate on oneor more electronic systems, define one or more specific machineimplementations that execute and perform the operations of the softwareprograms. Examples of computer programs or computer code include machinecode, for example is produced by a compiler, and files includinghigher-level code that are executed by a computer, an electroniccomponent, or a microprocessor using an interpreter.

A computer program (also known as a program, software, softwareapplication, script, or code) can be written in any form of programminglanguage, including compiled or interpreted languages, declarative orprocedural languages, and it can be deployed in any form, including as astand alone program or as a module, component, subroutine, object, orother unit suitable for use in a computing environment. A computerprogram may, but need not, correspond to a file in a file system. Aprogram can be stored in a portion of a file that holds other programsor data (e.g., one or more scripts stored in a markup languagedocument), in a single file dedicated to the program in question, or inmultiple coordinated files (e.g., files that store one or more modules,sub programs, or portions of code). A computer program can be deployedto be executed on one computer or on multiple computers that are locatedat one site or distributed across multiple sites and interconnected by acommunication network.

As used in this specification and any claims of this application, theterms “computer”, “server”, “processor”, and “memory” all refer toelectronic or other technological devices. These terms exclude people orgroups of people. For the purposes of the specification, the termsdisplay or displaying means displaying on an electronic device. As usedin this specification and any claims of this application, the terms“computer readable medium” and “computer readable media” are entirelyrestricted to tangible, physical objects that store information in aform that is readable by a computer. These terms exclude any wirelesssignals, wired download signals, and any other ephemeral signals.

It is understood that any specific order or hierarchy of steps in theprocesses disclosed is an illustration of example approaches. Based upondesign preferences, it is understood that the specific order orhierarchy of steps in the processes may be rearranged, or that allillustrated steps be performed. Some of the steps may be performedsimultaneously. For example, in certain circumstances, multitasking andparallel processing may be advantageous. Moreover, the separation ofvarious system components illustrated above should not be understood asrequiring such separation, and it should be understood that thedescribed program components and systems can generally be integratedtogether in a single software product or packaged into multiple softwareproducts.

Various modifications to these aspects will be readily apparent, and thegeneric principles defined herein may be applied to other aspects. Thus,the claims are not intended to be limited to the aspects shown herein,but is to be accorded the full scope consistent with the languageclaims, where reference to an element in the singular is not intended tomean “one and only one” unless specifically so stated, but rather “oneor more.” Unless specifically stated otherwise, the term “some” refersto one or more.

Various terms used herein have special meanings within the presenttechnical field. Whether a particular term should be construed as such a“term of art,” depends on the context in which that term is used.“Connected to,” “in communication with,” or other similar terms shouldgenerally be construed broadly to include situations both wherecommunications and connections are direct between referenced elements orthrough one or more intermediaries between the referenced elements,including through the Internet or some other communicating network.“Network,” “system,” “environment,” and other similar terms generallyrefer to networked computing systems that embody one or more aspects ofthe present disclosure. These and other terms are to be construed inlight of the context in which they are used in the present disclosureand as those terms would be understood by one of ordinary skill in theart would understand those terms in the disclosed context. The abovedefinitions are not exclusive of other meanings that might be impartedto those terms based on the disclosed context.

Words of comparison, measurement, and timing such as “at the time,”“equivalent,” “during,” “complete,” and the like should be understood tomean “substantially at the time,” “substantially equivalent,”“substantially during,” “substantially complete,” etc., where“substantially” means that such comparisons, measurements, and timingsare practicable to accomplish the implicitly or expressly stated desiredresult.

Additionally, the section headings herein are provided for consistencywith the suggestions under 37 CFR 1.77 or otherwise to provideorganizational cues. These headings shall not limit or characterize theinvention(s) set out in any claims that may issue from this disclosure.Specifically and by way of example, although the headings refer to a“Technical Field,” such claims should not be limited by the languagechosen under this heading to describe the so-called technical field.Further, a description of a technology in the “Background” is not to beconstrued as an admission that technology is prior art to anyinvention(s) in this disclosure. Neither is the “Brief Summary” to beconsidered as a characterization of the invention(s) set forth in issuedclaims. Furthermore, any reference in this disclosure to “invention” inthe singular should not be used to argue that there is only a singlepoint of novelty in this disclosure. Multiple inventions may be setforth according to the limitations of the multiple claims issuing fromthis disclosure, and such claims accordingly define the invention(s),and their equivalents, that are protected thereby. In all instances, thescope of such claims shall be considered on their own merits in light ofthis disclosure, but should not be constrained by the headings set forthherein.

1-20. (canceled)
 21. A method for providing approved content from acontrolled content repository, the method comprising: establishing anaccess protocol for a controlled content repository, wherein approvedcontent is stored in the controlled content repository and is accessibleaccording to the access protocol, wherein the access protocol is usedfor determining if the approved content in the controlled contentrepository can be used to generate a first electronic user interfaceassociated with a first computing device, and wherein the approvedcontent comprises or is generated based on first data associated with afirst object and second data associated with a second object; receiving,from a second computing device, the first data associated with the firstobject and the second data associated with the second object; providingthe approved content in the controlled content repository to the firstcomputing device after a determination that the approved content in thecontrolled content repository is authorized to be made available to thefirst computing device in accordance with the access protocol, whereinthe first electronic user interface associated with the first computingdevice is generated based on the first data associated with the firstobject and the second data associated with the second object; receiving,from the first computing device, first source data and second sourcedata; aligning or correlating the first source data with the first dataassociated with the first object; and aligning or correlating the secondsource data with the second data associated with the second object. 22.The method of claim 21, wherein the first data associated with the firstobject comprises at least one of a first definition or a first workflowassociated with the first object.
 23. The method of claim 21, whereinthe first source data and the second source data are stored in a sourcerepository separate from the controlled content repository.
 24. Themethod of claim 21, wherein the first data associated with the firstobject and the second data associated with the second object are storedin the controlled content repository.
 25. The method of claim 21,wherein the first source data is associated with at least one of a firstsubject or a second subject.
 26. The method of claim 25, furthercomprising aggregating the first source data associated with the atleast one of the first subject or the second subject.
 27. The method ofclaim 26, further comprising obfuscating the first source dataassociated with the at least one of the first subject or the secondsubject to remove subject identification information associated with theat least one of the first subject or the second subject.
 28. The methodof claim 27, further comprising initiating storage of electronicallycaptured data comprising the aggregated and obfuscated first source dataassociated with the at least one of the first subject or the secondsubject.
 29. The method of claim 28, further comprising mapping orcorrelating, using a customized electronic data capture system, theelectronically captured data to the first object and the second object.30. The method of claim 21, wherein the first source data is associatedwith a first event.
 31. The method of claim 30, wherein a secondelectronic user interface associated with the second computing device isused for generating a definition for the first event and a workflow forthe first event.
 32. The method of claim 30, wherein the firstelectronic user interface enables navigation between the first event anda first subject associated with the first source data.
 33. The method ofclaim 30, wherein the first event comprises or is part of a firstclinical trial.
 34. The method of claim 30, further comprising enablingthe first computing device to access an updated definition of the firstobject prior to the first event.
 35. The method of claim 21, furthercomprising extending the first object to generate a third object,wherein the third object is correlated to the first object, wherein thefirst electronic user interface associated with the first computingdevice is generated further based on the third object.
 36. The method ofclaim 21, further comprising validating the first source data and thesecond source data.
 37. A system for providing approved content from acontrolled content repository, comprising: a controlled contentrepository for storing approved content, wherein the controlled contentrepository is accessible according to an access protocol, wherein theaccess protocol comprises at least one set of access rules, wherein theaccess protocol enables determining if the approved content within thecontrolled content repository can be made available to a first computingdevice via an electronic user interface, wherein the approved contentcomprises or is generated based on first data associated with a firstobject and second data associated with a second object; and acontrolling computing device, in communication with the controlledcontent repository, providing the approved content within the controlledcontent repository to a first computing device after a determinationthat the approved content within the controlled content repository isauthorized to be made available to the first computing device inaccordance with the access protocol, wherein the electronic userinterface is generated based on the first data associated with the firstobject and the second data associated with the second object, whereinthe electronic user interface is used for initiating receipt ortransmission of source data associated with a first subject, and whereinthe source data is mapped, correlated, or aligned to the first dataassociated with the first object and the second data associated with thesecond object.
 38. The system of claim 37, further comprising aspecialized electronic data capture system for obfuscating the sourcedata, and mapping, correlating, or aligning the source data to the firstdata associated with the first object and the second data associatedwith the second object.
 39. A method for providing content from acontrolled content repository, the method comprising: establishing anaccess protocol for a controlled content repository, wherein content isstored in the controlled content repository and is accessible accordingto the access protocol, wherein the access protocol is used fordetermining if the content in the controlled content repository can beused to generate a first electronic user interface associated with afirst computing device, and wherein the content comprises or isgenerated based on first data associated with a first object and seconddata associated with a second object; receiving, from a second computingdevice, the first data associated with the first object and the seconddata associated with the second object; providing the content in thecontrolled content repository to the first computing device after adetermination that the content in the controlled content repository isauthorized to be made available to the first computing device inaccordance with the access protocol, wherein the first electronic userinterface associated with the first computing device is generated basedon the first data associated with the first object and the second dataassociated with the second object; and receiving, from the firstcomputing device, source data, wherein the source data is mapped,aligned, or correlated to the first data associated with the firstobject and the second data associated with the second object.
 40. Themethod of claim 39, wherein the mapping, aligning, or correlating isperformed by an electronic data capture application specific integratedcircuit having access to one or more mapping, alignment, or correlationrules, respectively, in the controlled content repository.